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Adjuvant
A substance added to a drug to aid its action, specifically in increasing
immune response.
Agent
studies
In cancer prevention trials, studies that look at whether taking
certain medications, vitamins, minerals, or food supplements can
prevent cancer.
Cancer
The general term covering more than 100 diseases characterized by
abnormal and uncontrolled growth of cells.
Chemotherapy
Treatment with anticancer drugs.
Control
Group
In a clinical trial, the participants who receive, depending on
the study, either standard treatment or a placebo.
Double-blind
A process used to prevent bias in a clinical study. Neither participants
nor physicians know who is taking the study agent and who is not.
Intervention
Group
The participants in a trial who receive the medication or study
agent being tested.
Investigator
The experienced clinical researcher who prepares a treatment plan
and implements it with a patient.
Lymphedema
Arm swelling, a complication that can occur with breast cancer treatment.
Phase
I, II, or III Trials
In cancer prevention clinical trials, each step, or phase, is designed
to answer different questions about the study agent. The first two
phases include only a small number of participants, but the third
can involve hundreds of sites and thousands of participants.
Phase
I: researchers seek to find the best way to give a new treatment
and how much can be given safely. These studies are offered only
to patients whose cancer has spread and who can't be helped by other
known treatments.
Phase
II: the study focus is on learning whether the agent has a biologic
effect in preventing cancer. If a treatment shows activity against
cancer in Phase II, it moves to Phase III.
Phase
III: these trials compare a promising new agent to the standard
one or to no agent. Trials involve two groups: the intervention
group and the control group.
Placebo
A tablet or capsule that looks like the medication being tested
but doesn't contain any active ingredient.
Protocol
An action plan for a clinical trial. It states what a study will
do, how, and why. It explains the number of people to be studied,
who is eligible, what they will take, what tests they will receive
and how often, and what information is gathered.
Randomization
Participants are assigned by chance, often by a computer, either
to receive the study agent (intervention group) or not (control
group).
Sentinel
Node
The lymph node to which breast cancer or melanoma cells are likely
to travel first.
Single-blind
Patients do not know which of the trial treatments they are receiving,
to prevent personal bias from influencing their reactions and study
results.
Sponsor
The agency or firm responsible for financing a clinical study.
Study
Arm
In clinical trials, patients assigned to one part or segment of
a study receiving a specific treatment.
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