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A key step
in any clinical trial is to carefully delimit the study population
by formulating clear inclusion and exclusion criteria. In this
hypothetical study we will evaluate ambulatory adult patients
with colorectal cancer receiving continuous infusion chemotherapy
for at least 4 cycles. Cycles are repeated every 5 weeks. Not
all patients receiving chemotherapy will develop mucositis-related
oral and throat pain. We will be including only those patients
in cycle 1 that develop mouth and throat pain. The specific inclusion
and exclusion criteria follow.
Inclusion
Criteria
To be eligible for inclusion in this clinical trial, the patient
must:
- Be willing
and able to provide written informed consent for study participation;
- Be eligible
for and scheduled to receive continuous chemotherapy for at
least 4 cycles;
- Be older
than 18 years of age; and
- Be willing
to complete protocol-specific evaluations and diary entries.
Exclusion
Criteria
Patients ineligible for this clinical trial include those with
any of the following conditions:
- Presence
of any mucositis or oral and throat pain prior to starting chemotherapy;
- Pregnancy
or breastfeeding;
- Use of
any unapproved agent for the prevention and/or treatment of
mucositis within 30 days prior to Study Day 1 and throughout
the duration of the Study Period; and
- Participation
in a clinical research study for mucositis within the last 30
days prior to enrollment.
Multiple
sites will be used to recruit patients in order to enroll enough
patients to make the study results significant. The number of
patients that need to be enrolled needs to be predetermined, especially
for a phase III study, because the goal is to assess efficacy
for a larger population. Whether or not you are familiar with
statistics for medical research, consulting with a statistician
would be the best way to determine the number of patients needed.
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