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GLOSSARY

Community Clinical Oncology Program (CCOP)

The Community Clinical Oncology Program (CCOP) links community physicians with the NAtional Cancer Institute (NCI) clinical research programs so more cancer patients may participate in clinical trials in their own communities.

Chemotherapy

Chemotherapy is the use of drugs to try to stop or slow the growth of cancer cells. It often is used in combination with other treatments (radiation therapy or surgery). Chemotherapy can be administered orally (capsule, pill, or liquid), by injection into a vein, artery, or muscle, or by intravenous (IV) drip. Chemotherapy affects rapidly growing cells, which may be cancerous or normal (such as hair cells, bone marrow). Some side effects of chemotherapy include hair loss, mouth sores, nausea, and vomiting.

Cancer Information Service (CIS)

The Cancer Information Services (CIS) is a national information and education network and a free public service of the National Cancer Institute (NCI). The CIS meets the information needs of patients, the public, and health professionals. Specially trained staff provide the latest scientific information in understandable language. CIS staff answer questions in English and Spanish and distribute NCI materials.

Clinical Trial

Clinical trials are research studies that evaluate new treatment options. Clinical trials are conducted in health care settings with voluntary patient-participants.

Control Group

The control group of patients in a clinical trial receives current standard care and/or placebo. Results of the control group are compared to results of the treatment group--the patients who received the new treatment. When no standard care exists for a condition, the control group would receive no treatment, which may be a placebo. Patients are told if this is a possibility. No patient is placed in a control group without treatment if any beneficial treatment is known and most cancer treatment clinical trials do not use placebo because standard care is available to use as a control. (See Treatment Group.)

Double-blinded

Double-blinded clinical trials are those in which the patients and the scientist do not know which treatment each patient is receiving. Blinding a study prevents personal bias from influencing their reactions and the study results. Treatment can be quickly identified, if necessary, by a special code. (See Single-blinded.)

Food and Drug Administration (FDA)

The United States Food and Drug Administration (FDA) is a public health agency, charged with protecting U.S. consumers by enforcing the Federal Food, Drug, and Cosmetic Act and related public health laws. In deciding whether to approve new drugs, the FDA itself does not conduct research; rather it examines the results of studies conducted by the manufacturer. The FDA must determine that the new drug produces the expected benefits without causing side effects that outweigh those benefits.

Gene Therapy

Gene therapy is the transfer of normal or redesigned genes into a patient to reduce or cure a disease state. Certain potentially cancerous genes are dormant in all of us and are sometimes triggered into activity. Other genes, tumor-suppressor genes, act naturally to stop unregulated growth of cancer cells. Since the early 1990s, scientists have conducted clinical trials to stop or reverse the activation of cancerous genes or to increase the number and effectiveness of tumor-suppressor genes.

Immunotherapy

Immunotherapy (also known as biological therapy) is a relatively new form of cancer therapy that tries to enhance the body's own defenses to fight cancer cells. Scientists try to stimulate or replace immune system cells to help destroy or prevent the growth of cancer cells. Biological agents that have shown success in triggering an immune response against some cancers include interferons, interleukins, colony-stimulating factors, T cells, tumor vaccines, tumor necrosis factors, and gene therapy.

Informed Consent

Informed consent is a process by which a person learns the details about a clinical trial and agrees to participate. The scientist explains the purpose of the trial, expected benefits and known risks, and what is expected of the patient-participant. The scientist also answers any questions. If the patient agrees to participate in the trial, she or he signs an informed consent document acknowledging that the trial was explained and is understood.

Institutional Review Board (IRB)

An Institutional Review Board (IRB) is an objective, multidisciplinary group of individuals that reviews and approves or disapproves clinical trials for a medical institution. The Board is made up of doctors from different specialties, ethicists (often a chaplain), administrators, and members of the public. An IRB is required by the U.S. Food and Drug Administration (FDA) to ensure protection of the rights and welfare of patients who are enrolled in clinical trials.

Multidisciplinary

Made up of many disciplines or specialties. A multidisciplinary health care center has expert resources available in several medical and surgical specialties as well as nutritional and lifestyle experts, educators, and other professionals.

National Cancer Institute (NCI)

The National Cancer Institute (NCI) was established under the National Cancer Act of 1937. It is the United States’ primary agency for cancer research and training. The NCI coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients.

Physicians Data Query (PDQ)

PDQ is a computerized database supported by the National Cancer Institute. It offers the latest information on standard treatments and ongoing clinical trials for each type and stage of cancer. The information is easily accessible online via medical libraries and personal computers.

Placebo

A placebo is an inactive substance with no medicinal effects that sometimes is used in research control groups.

Protocol

A protocol is a treatment plan or outline. In clinical trials, a protocol is the plan for using an experimental procedure or treatment.

Radiation Therapy

Radiation therapy, or radiotherapy, involves the delivery of high-energy x-rays, electron beams or radioactive isotopes (chemicals) over time to destroy cancer cells, to prevent the spread of cancer, or to shrink a tumor. Radiation therapy may be external or internal. External radiation therapy directs a beam at the tumor site. Internal radiation therapy may be administered by intravenous (into the vein) injection, intracavity implantation (e.g. in the uterus), or interstitial (into the tumor) insertion. Radiation works by damaging the DNA of malignant cells. Normal cells recover more fully from radiation therapy than do cancer cells. General side effects of radiation therapy may include fatigue, skin changes, and loss of appetite. Other site-specific side effects can occur and should be discussed with a physician.

Side Effect

A side effect is a secondary and usually undesirable effect from a drug or other treatment. For example, nausea is a common side effect of some anticancer drugs.

Single-blinded

Single-blinded clinical trials are those in which either the patients or the scientist do not know which treatment the patients are receiving. Blinding a study prevents personal bias from influencing reactions and the study results. Treatment can be quickly identified, if necessary, by a special code. (See Double-blinded.)

Standard Care

Standard care is a treatment currently used and considered the most effective based on past clinical trials.

Treatment Group

The treatment group of patients in a clinical trial receives the new treatment. Results of the treatment group are compared to results of the control group—the patients who received standard care. Then scientists are able to judge whether the new treatment is as good as or better than current standard care. (See Control Group.)


 

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