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6.0
This
study consists of two sequential studies: (a) a randomized,
double-blind, placebo-controlled, crossover study evaluating
SOYEST as a treatment for hot flashes, and (b) an optional
continuation study to obtain longer-term data about the
effectiveness of SOYEST used for this purpose. In a preceding
trial of megestrol acetate for hot flashes (NCCTG 90-92-55),
the open-label continuation phase provided valuable confirmatory
information regarding the dynamics of hot flashes with the
initiation and discontinuation of the study medication.
Before the study begins, there will be a one-week baseline
observation period in which baseline symptoms will be recorded.
6.1
Double-blind study
6.11 Registration procedures
6.111
To register a patient, call (555-555-5555) or fax a completed
eligibility checklist (555-555-5555) to the Randomization
Center between 8 a.m. and 4:30 p.m. central time Monday
through Friday.
6.112
IRB approval(s) is required for each treating site and a
signed 310 form(s) is to be on file at the Randomization
Center before patient accrual.
6.113 Patient eligibility and the existence of a
signed consent form will be checked by Randomization Center
personnel before a patient will be registered into this
study.
6.114
Treatment on this protocol must commence by the accruing
membership under the supervision of a NCCTG member physician.
6.115 Pretreatment tests must be completed within
the guidelines specified on the test schedule.
6.116
Treatment cannot begin prior to registration and must begin
within 28 days after registration.
6.117
Study medication availability checked.
6.12
Randomization procedures
6.121
After the patient has been registered onto the study, the
values of the stratification factors (Section
5.0) will be recorded, and the patient will be randomly
assigned to one of the following treatment groups:
-
SOYEST or
-
an identical-appearing placebo
6.122
To ensure that both the patient and the medical professionals
who care for the patient are blinded to the identity of
the treatment assignment, the randomization specialist will
follow the double-blinding procedures outlined below.
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