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Cancer Treatment

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Welcome to  my compendium website
on the  Cancer Care, Cause and Treatment Information Along With Frequently Asked Questions.
See the following categories below.

Causes of Cancer
Environmental causes of cancer
Signs of hereditary cancer
Types of Cancer
 Carcinomas   Sarcomas Leukemias Lymphomas
Cancer Basics
 What is Cancer?
 Symptoms of Cancer
Diagnosis of Cancer
Biopsy
 Endoscopy
Diagnostic imaging
 Blood tests
Current methods of cancer treatment
Surgery
Chemotherapy
Radiation
Immunotherapy 
Gene Therapy
Clinical Trials
Prevention of Cancer
Just the Facts…Smoking & Tobacco Use
Smoking Cessation Programs for Patients and the Public
 What are Clinical Trials

Why are clinical trials important?
 Who are the members of the clinical trials team?
What are the types of clinical trials?
What are the Phases of Clinical Trials?
Phase I Trials – Determine safety
 Phase II Trials – Determine whether the new treatment works
Phase III Trials – Study whether the new treatment is better
than standard treatment
Phase IV Trials – Find more information about the new treatment
Participating in Clinical Trials
View Studies by Cancer Type
View Studies by Cancer Treatment
View Studies by Study Number
View Studies by Physician
View Studies by Phase
Frequently Asked Questions about Clinical Trials
What Should I consider before Participating in a Clinical Trial
Some Possible Benefits
Sine Possible Risks
Do Cancer Patients Ever Receive Placebos in a Clinical Trial
Who Sponsors Clinical Trials
Do Patients Pay for Clinical Trials
How Do Patients Find a Clinical Trial


 Contact information for this Website:
Brian Nelson
Webpage Marketing Consultant 
31 Gessner Rd. ,  Houston, TX 77024
713-467-3025  Fax 713-467-3192
 Click: E-mail me

You can find this site again  by typing in the  Google search engine 
 the unique word " 1tnemtaerTrecnaC "  which is  OR
" CancerTreatment1 " backwards.19,666 words on this large website.

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You are at: http://www.IamFightingCancer.com/CancerTreatment/InformationFAQ.html   ud 07/30/2007 08:53 PM -0500  Bookmark this page now!

Misspelled words used to find this page 1 of 3.1RECNAC  cancer, censer, cancel, cencel, cansel, censel, cacer, cencer, canser, caner, canel, cainl, cainr, ceiner, ceinel, cance, cence, canse, cense, canc, cenc, cancre, camcer, canecr, cacner, cnacer, acncer, cancr, cncer, ancer, feetiegnt, feediegnt, feedeigng, fediegnt, fedeigng, feadiegnt, feadeigng, feeting, feedeignt, feeding, feting, fedeignt, feetint, feadeignt, fetint, feediegng, feeing, feetiegng, fediegng, feedng, fetiegng, feadiegng, feedig, feedyng, feadyng, fedyng, feedynt, feadynt, feading, fedynt, feding, feedint, feadint, fedint, fieng, feieng, feaing, feing, feeint, feaint, feint, feetin, feedan, feedin, fetin, fedan, feedyn, feetiegn, feadan, fedin, fetiegn, feedeign, fedyn, fedeign, feadin, feadeign, feadyn, feediegn, feeden, fediegn, feden, feadiegn, feaden, fd1ng, phd1ng, f3d1ng, f3d1mg, fed1ng, feedign, feednig, feeidng, fedeing, efeding, tube, chube, tueb, tbue, utbe, phd, food, foud, phood, phoud, fd, fod, fodo, ofod.  Trigeminal Neuralgia aka tic douloreau, Information Page,TN,  Pain Management, Neurontin.   anti-depressant drugs  pain relieving effects.    medication   undesirable side effects, neurosurgical procedures relieve pressure  nerve sensitivity.   reduced or relieved pain   alternative medical therapies such as acupuncture, chiropractic adjustment, self-hypnosis or meditation.Trigeminal Neuralgia, tic doloreaux, tic douloureux, Trigeminal disorder, what is Trigeminal Neuralgia, Carbamazepine is available as Tegretol. A newer medication is oxcarbazepine, available as Trileptal. Extended release carbamazepine is available as Carbatrol and Tegretol XR. TN, trigeminal neuralgia surgery, trigeminal neuralgia treatment, tic dolorue, trigeminal neurolgia, trigeminal, trigeminal neuropathy, trigeminal neuralgia cure, trigeminal nerve surgery, trigeminal neualgia, trigeminal neuralga, trigeminal nueralgia, mri of trigeminal nerve, trigeminal neuralgias, Trigeminal Neuralgia symptom, Trigeminal Neuralgia research, information on Trigeminal Neuralgia, trigeminal nerve injury, trigeminal nerve damage, trigeminal cranial nerve, trigeminal neralgia, tic douloureaux, symptom of tic douloureux,   Trigeminal Neuralgia (tic doloreaux) information Trigeminal Neuralgia - Trigeminal neuralgia (TN), also known as tic douloureux, is a pain syndrome recognizable by patient history alone. The condition is characterized by pain often accompanied by a brief facial spasm or tic. Pain distribution is unilateral and follows the sensory distribution of cranial nerve V, typically radiating to the maxillary (V2) or mandibular (V3) area. Physical examination eliminates alternative diagnoses. Signs of cranial nerve dysfunction or other neurologic abnormality excludes the diagnosis of idiopathic,glossopharyngeal, face pain, atypical face pain, atypical trigeminal neuralgia, TN, ATN, ATFP, AFP, GN, orofacial, cranio-facial, gum pain, gingival pain, cheek pain, orofacial, cranio-facial,facial neuralgia, face neuralgia, trigeminal neuralgia, tic douloureux, glossopharygeal neuralgia, face pain, facial pain, atypical face pain, atypical trigeminal neuralgia, TN, ATN, ATFP, AFP, GN, Trigeminal Neuralgia Resources, myofascial, orofacial, cranio-facial, gum pain, gingival pain, cheek painTrigeminal neuralgia, also called ticdouloureux, the most frequent of all neuralgias, causes severe, stabbing, paroxysmal pain on one side of the face. It is characterized by a sudden, severe, electric shock-like or stabbing pain typically felt on one side of the jaw or cheek. The cause of trigeminal neuralgia is unknown, but the disorder occurs most frequently in middle or old age (more common in women than in men,trigeminal neuralgia, face, facial pain, nerve, forehead, eye, cheek, jaw, tumor, arteriovenous malformation, multiple sclerosis, anticonvulsants, Tegretol, carbamezapine, Dilantin, phenytoin Neurontin, gabapenti, Baclofen, lioresal, microvascular decompression, MVD, Gamma knife, radiosurgery, percutaneous, glycerol rhizotomy, alternative surgery, glossopharyngeal neuralgia, cranial nerve, trigeminal, facial pain, face, cheek, jaw, stabbing, electricTrigeminal Neuralgia - Aretaeus of Cappadocia, known for one of the earliest descriptions of migraine, is credited with the first indication of trigeminal neuralgia (TN). headache "spasms and distortions of the countenance took place." John Fothergill was the first to give a full and accurate description of TN in a paper titled "On a Painful Affliction of the Face,"  presented to the medical society of London in 1773. Nicholaus Andre coined the term  trigeminal neuralgia, fothergill syndrome, fothergill's syndrome, tic douloureux, tn  The Merck Manual 
Causes of Cancer
 The vast majority of cancers--about 80%--are considered sporadic, meaning that there is no clear cause. For some reason, certain normal genes begin to mutate (change), multiplying rapidly and becoming malignant. There are several environmental influences that may cause these gene mutations to occur. In fact, a large number of cancers are preventable because most of these factors can be controlled with healthy lifestyle choices. 

Environmental causes of cancer include:

  • Age: cancer is most common among people over the age of 50. 
  • Diet: high-fat, high-cholesterol diets are proven risk factors for several types of cancer, particularly colon cancer
  • Obesity: although no clear link has been established, research indicates obesity may be a contributing factor to some cancers.
  • Cigarettes greatly increase the lung cancer risk, even among non-smokers forced to inhale secondhand smoke. Other tobacco products, like pipes and chewing tobacco, are linked to cancers of the mouth, tongue and throat.
  • Long-term exposure to chemicals like asbestos, radon and benzene
  • Exposure to high levels of radiation
  • Harmful ultraviolet rays from the sun are directly linked to melanoma and other forms of skin cancer
  • Some viruses, including hepatitis B and C, human papillomaviruses (HPV), and the Epstein-Barr virus, which causes infectious mononucleosis, have been associated with increased cancer risk 
  • Immune system diseases, like AIDS, can make one more susceptible to some cancers

The other 20% of cancers are hereditary.  This means that the abnormal gene responsible for causing the cancer is passed from parent to child, posing a greater risk for that type of cancer in all descendants of the family. However, just because someone has a cancer-causing gene doesn't mean they will automatically get cancer. If hereditary cancer is suspected, family members should consider genetic counseling and testing to determine their risk.  Regular cancer screenings are recommended for high-risk families so that if cancer does occur, it will be diagnosed in the early stages, when it's most responsive to treatment.

Signs of hereditary cancer include:

  • Several relatives with cancer
  • Cancers that occur at an earlier age than normal
  • Multiple or bilateral cancers: for example, a person with breast cancer who also develops ovarian cancer
  • Rare or unusual types of cancer
  • Ethnic background: some cancers are more common among certain population groups
 

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Types of Cancer
 There are many different types of cancer.  Several factors, including location and how the cancerous cells appear under the microscope, determine how cancer is diagnosed.  For example, there are several forms of breast cancer, classified according to where the tumors originate within the breast, and their tendency to invade surrounding organs and tissue. All cancers, however, fall into one of four broad categories:

Carcinomas are tumors that arise in the tissues that line the body's organs. About 80% of all cancer cases are carcinomas.
 

Sarcomas are tumors that originate in bone, muscle, cartilage, fibrous tissue or fat.
 

Leukemias are cancers of the blood or blood-forming organs.

Lymphomas affect the lymphatic system, a network of vessels and nodes that acts as the body's filter. The lymphatic system distributes nutrients to blood and tissue, and prevents bacteria and other foreign "invaders" from entering the bloodstream.   There are over 20 types of lymphoma. 

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Cancer Basics

What is Cancer?
Cancer isn't just one disease. It is a large and complex family of malignancies that can affect virtually every organ in the body. Cancer is second only to heart disease as the leading cause of death in the United States. Over 1.2 million new cases are diagnosed every year, with half of them occurring in the lung, prostate, breast, colon and rectum. Cancer can strike at any age, although it is most common in people over 50.  

Cancer begins in the body's cells, which are constantly dividing and multiplying to replace old, damaged cells. Sometimes, cells begin to divide unnecessarily, forming excess tissue known as a tumor. In most cases, tumors are benign, meaning that they are not cancerous. Benign tumors, although they may cause some health problems depending on their size and location, are not life-threatening.

However, if an abnormal cell begins to divide, it eventually forms a malignant, or cancerous tumor. Most malignant tumors grow quite rapidly, invading nearby organs and tissues. Cancerous cells can also travel through the bloodstream to other regions of the body. When cancer spreads from its original site, the process is known as metastasis. 

The good news is that cancer death rates have been declining in recent years, especially among men, who generally experience higher rates than women. Increasing public awareness has resulted in more people getting regular cancer screenings, and practicing healthy lifestyles to reduce their risk. 

  Symptoms of Cancer
Unfortunately, many types of cancer don't display any obvious symptoms or cause pain until well advanced.  Because early-stage cancer symptoms tend to be subtle, they are often mistaken for signs of other, less-threatening diseases. Here are the seven warning signs of cancer:
  • Changes in bowel or bladder habits
  • A sore that does not heal
  • Unusual bleeding or discharge
  • Thickening or lump in the breast or any other part of the body
  • Indigestion or difficulty swallowing
  • An obvious change in a wart or mole
  • A nagging cough or hoarseness

 

Some symptoms are specific to certain types of cancer, such as difficult urination for prostate cancer, or flu-like symptoms for acute leukemias. Don't be afraid to discuss unusual symptoms with your doctor!  Diagnostic tests are available for most common cancers. If diagnosed early, your chances of surviving cancer are greatly increased. 
12 Common Cancer Myths Debunked
A nationally representative telephone survey by the American Cancer Society of nearly 1,000 U.S. adults who had never been diagnosed with cancer revealed a surprising number agreed with inaccurate or unlikely statements about cancer risk and prevention statements. Individuals with lower education levels were more likely to believe the myths. And men were more likely than women to be duped.

Myth 1. The risk of dying from cancer in the United States is increasing.
Myth  2. Living in a polluted city is a greater risk for lung cancer than smoking a pack of cigarettes a day.
 Myth 3. Some injuries can cause cancer later in life.
Myth 4. Electronic devices, like cell phones, can cause cancer in the people who use them.
 Myth 5. What someone does as a young adult has little effect on their chance of getting cancer later in life.
 Myth 6. Long-time smokers cannot reduce their cancer risk by quitting smoking.
 Myth 7. People who smoke low-tar cigarettes have less chance of developing lung cancer than people who smoke regular cigarettes.
Myth 8. Personal hygiene products, like shampoo, deodorant and antiperspirants, can cause cancer.
 Myth 9. Getting a mammogram, or using a special X-ray machine to detect breast cancer, can cause cancer of the breast.
Myth 10. Getting a base tan or base coat at a tanning salon will provide protection from skin cancer when you go outside in the sun.
 Myth 11. Underwire bras can cause breast cancer.
Myth 12. You cannot get skin cancer from using a tanning booth.

 Healthy behaviors depend partly on whether individuals can make an accurate assessment of risk factors for that disease. Unwarranted worry over unproven risk factors can distract attention from the valid risks, resulting in "risky" decisions," past research indicates. "If people hold erroneous beliefs about risk factors for cancer they might not be making informed decisions for their behaviors," said lead study author Kevin Stein. 

Diagnosis of Cancer
There is a wide array of methods to diagnose cancer. As researchers learn more about the mechanisms of cancer, new diagnostic tools are constantly being developed and existing methods refined. If your primary care physician suspects cancer, he or she may order some tests to confirm the diagnosis.  These tests can either be conducted by your physician or by oncologists at cancer centers like M. D. Anderson.  No matter who makes the diagnosis, a second opinion by a cancer expert is strongly recommended. Some types of cancer, particularly lymphomas, can be hard to classify, even for an expert.  Accurate identification of cancer allows oncologists to choose the most effective treatment. The most common diagnostic methods include: 

Biopsy: a small tissue sample is surgically removed and examined under a microscope for the presence of cancer cells. Depending on tumor location, some biopsies can be done on an outpatient basis with only local anesthesia. If the tumor is filled with fluid, a type of biopsy known as a fine needle aspiration is used. A long, thin needle is inserted directly into the suspicious area to draw out fluid samples for examination.

Endoscopy: a flexible plastic tube with a tiny camera on the end is inserted into body cavities and organs, allowing the physician to view the suspicious area.  There are many types of scopes, each designed to view particular areas of the body.  For instance, a colonoscope is used to detect growths inside the colon, and a laparoscope is used to examine the abdominal cavity.

Diagnostic imaging: several techniques are used to produce an internal picture of the body and its structures. Types of imaging methods include:

  • X-rays are the most common way doctors make pictures of the inside of the body. Specialists can spot abnormal areas that may indicate the presence of cancer.
  • CAT scan (computerized axial tomography), uses radiographic beams to create detailed computerized pictures taken with a specialized X-ray machine. It is more precise than a standard X-ray, and provides a clearer image.
    • Magnetic Resonance Imaging (MRI) uses a powerful magnetic field to create detailed computer images of the body’s soft tissue, large blood vessels and major organs. MRI is an accurate but expensive process, and patients must lie completely still during the procedure for best results.
    • Ultrasound uses high-frequency sound waves to determine if a suspicious lump is solid or fluid. These sound waves are transmitted into the body and converted into a computerized image.

    Blood tests: some tumors release substances called tumor markers, which can be detected in the blood.  A blood test for prostate cancer determines the amount of prostate specific antigen (PSA). Higher than normal PSA levels can indicate cancer.  Recently, a blood test for ovarian cancer, known as CA-125, has become available.  However, blood tests by themselves can be inconclusive, and other methods should be used to confirm the diagnosis

     

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    Treatment of Cancer
    There are four major types of cancer treatment: surgery, radiation therapy, chemotherapy, and immunotherapy. These therapies can be used either alone or in combination with each other. Location, size and stage of the tumor, as well as your overall health, determines which treatment or treatments you will receive. Many new treatments, including cancer vaccines and gene therapy, are being studied in clinical trials. 

    Patients at M. D. Anderson are treated by a team of specialists tailored to meet a patient's individual needs. The team may include a medical oncologist, a surgeon, a radiation oncologist, a pathologist, and other health care professionals. This multidisciplinary approach to cancer care was pioneered by M. D. Anderson.

    Current methods of cancer treatment:

    • Surgery is the oldest form of cancer treatment. About 60% of cancer patients will undergo some sort of surgery, either by itself or in combination with other therapies.
    • Chemotherapy uses powerful drugs to kill cancer cells, control their growth, or to relieve pain symptoms.
    • Radiation uses large doses of high-energy beams or particles to destroy cancer cells in a specifically targeted area.
    • Immunotherapy, also known as biologic therapy, stimulates the body's own defense systems to fight cancer. 
    • Gene Therapy identifies missing or defective genes that cause cancer or increase cancer risk, and replaces them with normal copies.
    • Clinical Trials, in which new treatment methods are tested on human subjects, can provide options for patients whose cancer has not responded to standard therapies. 
    Cancer
    Compendium Websites
    To Consider    		 Click Cancer- Head-Neck- Diagnosis Info  Cancer Chemotherapy Treatment Side Effects  
     Click Cancer Fighting Foods - Vegetables Healing Hope.
     Click Cancer Treatment using  Capsaicin Health Benefits     
     Click Dogs Detecting Cancer Fact or Fiction?
    Click Cancer Healing Foods Photo Directory 
    Click Rosemary's Cancer Fighting Food Recipes.
    Click Prostate Cancer  
     Click Rare Medical Problems
    Click Cancer Treatment
     Click Cancer & Malnutrition
     Click Cancer Head-Neck-Treatment Radiation Chemotherapy Info V1
         Click V2 NI Cancer-Chemotherapy Drugs-Side-Effects  
     Click     Cancer Feeding Tube
    Click My Story Parotid Gland Cancer of Jill Bates Father
    Click I Am Fighting Cancer.com Cancer Journal for Brian Nelson
    Click Lung Cancer
    Click Herceptin Trastuzumab Cancer Info FAQ
    Click My MD  Anderson Cancer Center
    Click Thoracentisis Lung Procedure
    Click Kirk Woodward's Non Small Lung Cancer Diary
    Click     Beating Cancer With Nutrition
    Prevention of Cancer
    Up to 85% of cancers can be prevented by avoiding environmental risk factors like smoking, sun exposure, alcohol abuse and poor nutrition. Of course, things like age, race, gender and family history cannot be changed, but knowing your personal cancer risk can help you devise a prevention strategy with regular screenings and healthy lifestyle choices. Having one or more risk factors for cancer doesn't mean you will get cancer. In fact, many people considered high-risk never develop cancer while others with no known risk factors become ill.
    Just the Facts…Smoking & Tobacco Use (pdf)
     Tobacco use, particularly cigarette smoking, is the single most preventable cause of death in the United States. The number of deaths per year from smoking exceeds the number of deaths per year from all accidents, suicides, drug use, homicides and AIDS combined. An estimated 45 million U.S. adults are smokers, and more than a third of all U.S. high school students smoke cigarettes.

    The good news is that no matter how old you are, it’s never too late to improve your health by kicking the tobacco habit for good


     
    Want to Quit? Treatment at M. D. Anderson
    Smoking Cessation Programs for Patients and the Public
    It's never too late to improve your health by kicking the tobacco habit. One of our studies may help. Call (713) 792-2265 for more information.
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    What are Clinical Trials? - Clinical trials are cancer research studies. Learn the basics and how they're conducted.

     

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      Clinical trials are cancer research studies that involve people. The main purpose of a clinical trial is to find a better way to prevent, Photo Collage of Researchers, Nursediagnose or treat a disease. Clinical trials are part of a long, careful research process. Patients who participate in a clinical trial receive drugs or procedures that already have been researched in successful laboratory and/or animal studies. Most clinical trials study new drugs or procedures, but some study drugs or procedures that have already received approval by the U.S. Food and Drug Administration.

    All patients who participate in clinical trials are volunteers. They can choose to stop their participation in a clinical trial at any time.

    Why are clinical trials important?
    Clinical trials are important to develop new treatments for cancer. Many of today’s standard cancer treatments are based on the results of previous clinical trials.

    Who are the members of the clinical trials team?

    Principal Investigator: The principal investigator, usually a doctor, is responsible for the design, development and conduct of the clinical trial. He or she evaluates data and helps participating doctors manage the trial. You will continue to see your primary doctor if he or she is not the principal investigator.

    Research Nurse: The research nurse directs and coordinates patient care during a clinical trial, and is a good contact for patients who have questions. He or she will:

    • Teach you about participation in the clinical trial
    • Make sure the protocol’s instructions are followed
    • Teach you about side effects
    • Help manage clinical trial data

    Clinic Nurse: The clinic nurse coordinates general patient care regardless of whether you participate in a clinical trial. He or she will meet with you during your doctor visits. Because the clinic nurse is a part of your health care team, you also may ask him or her questions.

    What are the types of clinical trials?

    Therapeutic trials test new drugs, surgery techniques, radiation therapy procedures or other treatment methods on people with specific types and stages of cancer.

    Prevention trials study how healthy people may prevent cancer. People at high risk of getting cancer may benefit from participation in a prevention trial.  

    Early-detection/screening trials discover ways to find early-stage cancer. 

    Diagnostic trials find new and better ways to determine if someone has cancer – and, if so, where the cancer is located in the body; how much cancer is there; and whether or not it has spread to other parts of the body. 

    Quality of life/supportive care trials seek to improve the comfort and quality of life of patients and their families or caregivers.



    What are the Phases of Clinical Trials? - Information on how new treatments progress from the laboratory to clinical usage.

     

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    After promising treatments are explored in animal and/or laboratory studies, researchers perform clinical trials. Once the drug, device or procedure enters the clinical trials process, it must go through several phases:

    • Phase I trials determine the safety of a new treatment
    • Phase II trials determine whether a certain kind of cancer responds to a new treatment
    • Phase III trials study whether a new treatment is better than standard treatment
    • Phase IV trials find more information about a new treatment that has been already approved for use in patients

    Graph of Clinical Trials Process

    Phase I Trials – Determine safety
    The goal of a Phase I trial is to find the safest dose of a new drug that patients can receive without creating harmful side effects. During a Phase I trial, the researcher also examines the best way to give a new drug, such as by mouth or intravenously (through a vein). 

    Throughout Phase I trials, researchers monitor whether the new drug shows any effect against cancer. However, because these trials often are testing drugs for the first time in people, the goal is to find out how to give the drug in a safe way, and not how well it fights cancer.

    Phase I trials usually include 15 to 30 people. Usually patients who have undergone standard treatments without success and have no other options are eligible to participate in a Phase I trial.

    Typically, patients in Phase I trials are divided into cohorts – small groups of patients – usually around three people. The first cohort receives a low dose of the new drug. Researchers may collect blood or urine samples to measure drug levels. If no severe side effects occur, then a new cohort receives a higher dose of the same drug. The dose increases with each new cohort until the researchers see too many side effects or until they determine the best dose.

    If the treatment successfully passes through a Phase I trial, then it will move forward to be studied in a Phase II trial.

    Phase II Trials – Determine whether the new treatment works
    The main goal of a Phase II trial is to examine how well the new treatment works to fight a certain kind of cancer. Less than 100 patients usually participate in a Phase II trial. Patients who volunteer for a Phase II trial may have been treated with chemotherapy, biotherapy, surgery or radiation and still need further treatment.

    In addition to evaluating how well the treatment works against the cancer, doctors continue to monitor side effects. Since more patients participate in Phase II studies, some of them may experience side effects that patients in the Phase I clinical trial did not have.

    If the new treatment seems to be effective against cancer in a certain percentage of patients, researchers may consider it successful enough to continue study in a Phase III clinical trial.

    Phase III Trials – Study whether the new treatment is better than standard treatment
    The goal of a Phase III trial is to compare the new treatment with the standard treatment. Researchers track whether a new treatment is better than, the same as, or less effective than the standard treatment.

    Phase III trials may include hundreds to thousands of patients around the country or world. In general, each patient enrolled in a Phase III clinical trial has an equal chance of participating in one of two or more arms (groups) of the study. In a clinical trial with two arms:

    • The control group receives the standard treatment
    • The investigational or experimental group receives the new treatment being tested

    Randomization is the process of assigning participants to groups. Randomization helps avoid bias in the clinical trial. Bias occurs when human choices or other factors not related to the treatment being tested change a study’s results.

    Neither the patient nor the doctor can choose whether the patient is in the control group or the experimental group. Regardless of which group a patient is assigned to, either he or she will receive the best standard treatment available or the new treatment that researchers believe is as good as, or better than, the standard treatment.

    Single Blind Versus Double Blind Trials

    • Single blind studies: patients do not know whether they are in the experimental or control group
    • Double blind studies: neither the patients nor the researchers know which patients are in each group (although this information is recorded and on file if needed)

    FDA Approval
    The role of the U.S. Food and Drug Administration (FDA) is to make sure medical treatments are safe and effective for people to use. Researchers submit their clinical trial results to the FDA, and based on the information, the FDA may approve the drug or treatment. Then it becomes available to all patients and sometimes becomes the new standard treatment.

    Phase IV Trials – Find more information about the new treatment
    Phase IV clinical trials are not as common as Phase I, Phase II and Phase III trials. In Phase IV trials, researchers study drugs and/or treatments that have already received FDA approval. The goal of Phase IV trials is to study how safe and effective a drug or procedure is over time.


     Information about enrolling in clinical studies and informed consent.

    Participating in Clinical Trials

    Photo of Researcher and PatientHow does M. D. Anderson protect patients?
    When conducting clinical trials, M. D. Anderson’s most important responsibility is to protect patients through well-designed protocols,
    a dedicated Institutional Review Board (IRB) and a careful informed consent process.

    Clinical Trial Protocol
    A protocol is a detailed plan that explains what will be done in a clinical trial and why. It outlines how many patients will participate, what medical tests they will receive and how often, and the treatment and monitoring plan. Researchers must follow the protocol approved by M. D. Anderson’s Institutional Review Board (IRB).

    If you have questions or concerns about safety while participating in a clinical trial, please contact a member of your clinical trial team. If you still have questions about the study or your rights as a participant, contact the Chairman of the Institutional Review Board (IRB) at (713) 792-2933.

    The Institutional Review Board
    M. D. Anderson has four Institutional Review Boards (IRBs). An IRB is a committee of people, such as doctors, nurses, scientists, dentists, chaplains, social workers, attorneys and patients who are responsible for protecting clinical trial participants and making sure that the trials follow federal laws.

    Photo of Institutional Review Board MembersBefore a clinical trial can begin, the IRB reviews and approves the protocol to make sure that it is based on reliable scientific evidence. The IRB attempts to ensure that the protocol will not cause excessive harm to any patient.

    After a clinical trial begins, the IRB monitors the trial at least once a year and stops it if any safety concerns arise. For example, if a patient developed dangerous side effects, then the trial would be stopped. It also may stop a clinical trial early if it becomes clear that the new treatment is much more effective than standard treatment, so that all participants may receive the better treatment.

    The FDA regulates M. D. Anderson’s IRBs by auditing IRB minutes, staff and facilities every five years. FDA officials also can visit M. D. Anderson at any time and review anything they choose related to clinical trials. 

    The Informed Consent Process
    If you have the option to participate in a clinical trial, you will go through a process called informed consent. You will learn details about a specific clinical trial so that you may decide whether to participate. The informed consent process protects patients by ensuring that they understand the clinical trial’s plan before agreeing to participate.

    Photo of Informed Consent DocumentThe researcher or nurse from the clinical trial team will review the informed consent form in detail with you. This form explains a specific clinical trial’s purpose, procedures, risks and benefits.

    You will be encouraged to ask questions about terms or ideas that are confusing. A family member or friend may be helpful by listening to the explanation, asking questions and recording answers. Some doctors encourage patients to bring tape recorders so they can review the information afterwards.

    You can take the informed consent form with you to think about whether you would like to participate in the clinical trial.

    Information on the Informed Consent Form

    Informed consent forms are different, but they should include:

    • The reason for the clinical trial (what the researchers hope to learn)
    • Who is eligible to take part in the clinical trial
    • What is known about the type of treatment being studied
    • The possible risks and benefits (based on what is known so far)
    • Other treatments that may be options
    • The clinical trial’s design (randomized, single blind, double blind, etc.)
    • Types of tests, the number of tests and doctor’s visits required
    • Who is responsible for the costs of the clinical trial (tests, doctor’s visits, etc.)
    • Who is responsible for the costs if a patient needs additional care as a result of the clinical trial 
    • A statement about conflicts of interest
    • A statement about protecting the patient’s privacy
    • A statement about the clinical trial being voluntary and the patient’s rights to leave the clinical trial at any time
    • Contact information for further questions

    Signing the Form
    If you want to participate in a clinical trial after learning all that is involved and what you would be expected to do, then you, the trial’s principal investigator (or nurse, if called for in the protocol) and a witness will sign and date three copies of the informed consent form. You will keep one copy, one will go in your medical file, and another will go in the principal investigator’s file.

    The informed consent process does not end once you sign the form. If new benefits, risks or side effects are found during a trial, the doctor must inform all of the participants.You will be encouraged to keep asking questions throughout the trial.

    M. D. Anderson will take appropriate steps to keep your personal information private. However, there is no guarantee of absolute privacy. The Food and Drug Administration (FDA), the IRB of M. D. Anderson and the clinical trial’s sponsor might review your record to collect data or to see that the research is being done safely and correctly. Under certain circumstances, the FDA could be required to reveal the names of participants.



     Clinical Trials at M. D. Anderson - a current list of clinical trials that are recruiting patients.

    Clinical Trials at M. D. Anderson Cancer Center

    View studies by cancer type
    Breast, prostate, colon cancer and others—use this site to see what clinical trials are now in progress for specific cancers.

    View studies by treatment
    Have you heard of a particular new treatment that is being studied? See if M. D. Anderson is one of the clinical trial sites for that treatment. Scroll down the list to "No Treatment Agents Listed" or "None" to view cancer prevention, diagnosis, control or other non-treatment clinical trials.

    View studies by study number
    Staff at M. D. Anderson are most likely to be familiar with the study numbers assigned to clinical trials. Look here if you know the number of the clinical trial that interests you.

    View studies by physician
    Have you heard of a certain M. D. Anderson doctor? Use this link to see what clinical trials that doctor is conducting.

    View studies by phase
    Clinical trials are conducted in phases from I to IV. Each phase tests specific aspects of experimental therapies, such as dosage, toxicity and effectiveness in comparison to standard treatments. More participants are enrolled as the trials progress through each phase.



    Frequently Asked Questions - Insurance coverage, costs, resources and more.

      Frequently Asked Questions About Clinical Trials

    What should I consider before participating in a clinical trial?
    Each clinical trial is unique and has its own benefits and risks.

    Some possible benefits of participation:

    • You may have more treatment options
    • If the new drug or treatment works, you may be among the first to benefit
    • You may be able to help future cancer patients
    • The trial sponsor may pay for some of your medical care or tests. (Ask your doctor or the research nurse about who is responsible for these costs before agreeing to participate.)

    Some possible risks include:

    • Side effects may be worse than standard treatment
    • Side effects may occur that the doctor does not expect
    • New treatments do not always turn out to be better than, or as good as, standard treatment
    • The new treatment may not work for you even if it works for other patients
    • Your health insurance company may not pay for your clinical trial care or tests. (Ask your doctor or the research nurse about who is responsible for these costs before agreeing to participate.)
    • You may have to receive all of your tests and treatment at M. D. Anderson. Depending on where you live, this may require more time and money for travel.

    What questions should I ask about participating in a clinical trial?
    As the patient, it is your decision whether to participate in a clinical trial. Since it is your choice, ask as many questions as you need until the answers are clearly understandable to you. For some examples, download our Questions to Ask About Clinical Trials document (pdf) to help get the information you need to make an informed decision.

    How will I know if I am eligible to participate in a clinical trial?
    Each clinical trial has eligibility criteria, which are requirements that patients must meet before they can participate. Eligibility criteria might include information about:

    • Age and sex
    • Type of cancer
    • Stage (extent) of the cancer
    • Previous treatments that you must, or must not, have had
    • Length of time since you last received treatment
    • Results of certain laboratory tests
    • Medicines that you are taking
    • Other medical conditions
    • Previous history of any other cancer
    • Other conditions that are specific to each clinical trial

    If you have found a clinical trial you might qualify for, talk to your doctor, or contact the clinical trial’s principal investigator or research nurse.

    Do cancer patients ever receive placebos (inactive medicines) in a clinical trial?
    Cancer patients in a clinical trial always receive the best standard treatment available or a new treatment that researchers believe is as good or better.

    A placebo is a substance that looks like medicine, but is not. Cancer patients are given placebos in a randomized trial only under unusual circumstances. If a placebo is used, researchers may give patients in the control group a placebo in combination with standard treatment to compare standard treatment alone to standard treatment with a new drug.

    Who sponsors M. D. Anderson’s clinical trials?
    The U.S. National Cancer Institute (NCI) sponsors many of M. D. Anderson’s clinical trials. Drug companies may also sponsor clinical trials. This is because these companies must show that their drugs and medical devices are safe and effective in order to receive FDA approval and become available to the public. M. D. Anderson and nonprofit organizations also sometimes sponsor clinical trials.

    How do M. D. Anderson patients pay for clinical trials?
    The clinical trial sponsor (whether it is the government or a company) may pay for the experimental treatment, special testing, extra doctor visits, travel time and travel expenses.

    Some health insurance companies also will cover routine costs in clinical trials. Some health insurance companies will cover the costs of procedures that patients would have even if they were not in a clinical trial (routine costs). For Medicare patients, routine costs are covered in all Medicare-qualified clinical trials.

    You will be responsible for any costs not covered by the clinical trial sponsor or your health insurance company. Therefore, be sure to ask questions before deciding to participate, especially to confirm what costs your health insurance company will cover.

    For financial assistance or questions about insurance coverage, call M. D. Anderson’s Patient Business Services at (713) 792-7188.

    After the clinical trial ends, what happens to the information and results?
    Researchers give patients a number or code to protect their identities. When the clinical trial results are published, patients’ names are not used. The research team may access clinical trial information to help the study sponsor submit data to the FDA for approval.

    If you want to read what has been published about a clinical trial that you participated in, contact your doctor. Ask for the name of the journal, date of publication, lead author and title of the study. The Learning Center staff can help you locate a copy of the article.

    How do patients find a clinical trial at M. D. Anderson?
    There are several ways to learn more about clinical trials conducted at M. D. Anderson:

    Where can I find additional information?

    M. D. Anderson Information Line: (800) 392-1611, option 3. Trained health information specialists provide information about M. D. Anderson’s clinical trials.

    National Cancer Institute’s Cancer Information Service: (800) 4-CANCER or (800) 422-6237. Trained information specialists can help callers determine whether they are eligible for various protocols.

    The Learning Center: a free consumer health library with the latest information on cancer care, support, prevention and general health and wellness issues. Locations provide a wide range of materials, and each site’s resources are different. Please call ahead to learn which location contains the resources you need. The Learning Center staff provides skilled, individualized service and will be happy to help you.

    The Learning Center provides materials for information and convenience only. They are not to be substituted for medical advice. Medical information is often controversial and continually changes. Please consult your health care provider to discuss your specific concerns.


     

     
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