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.
Clinical Trial
Clinical trials are research studies that
evaluate new treatment options. Clinical trials are conducted in health care
settings with voluntary patient-participants. They are broken down into 3 phases:
Phase I, Phase
II, Phase III
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.)
Epidemiology
Epidemiology from two Greek words 'epi', meaning on or akin to, and 'demos',
meaning people. Epidemiology is therefore the study of effects on people, namely
the health effects on people or populations.
Also defined as:
Epidemiology-- a discipline basic to all fields of public health, may be defined
as the study of the distribution and dynamics of disease in human populations.
Its purpose is to identify factors relative to people and their environment
which determine the occurrence of disease, and to provide a basis for programs
in preventive medicine and public health. Epidemiologic methods are also used
to assess the variance, severity and magnitude of disease and related risks
and resource needs, and to evaluate the efficacy of new preventive and therapeutic
treatments and the impact of new organizational patterns of health care delivery.
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.
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.
Randomized
clinical trial
A randomized clinical trial is a study in which patients with similar traits,
such as extent of disease, are assigned by chance to one of two groups. The
treatment group receives the new treatment. The control group receives the current
standard care. When no standard treatment exists, some studies compare a new
treatment with a placebo. Patients are told if this is a possibility before
deciding whether to take part in a study.
Why is randomization important?
Randomization is important to compare different treatments and assure a fair
and impartial test of the treatment being studied. The most effective way to
avoid influencing the results of the study is by random assignment of study
patients to a treatment group. Randomized studies often are blinded studies.
(See Double-blinded.)
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.)