Hot Flashes Clinical Trial
Official title:
Evaluation of a Biobehavioral Intervention for Hot Flashes
Rationale: Venlafaxine may help relieve hot flashes in women who have had breast cancer.
Hypnosis or focused attention may help control hot flashes in postmenopausal women. It is
not yet known whether giving venlafaxine together with hypnosis or focused attention is more
effective in treating hot flashes.
Purpose: This randomized clinical trial is studying venlafaxine together with hypnosis or
focused attention in treating patients with hot flashes.
Objectives:
I. To evaluate the effect of hypnosis plus venlafaxine versus focused attention with
venlafaxine versus hypnosis plus a placebo versus focused attention plus a placebo for
reducing hot flashes.
II. To evaluate the side effects associated with hypnosis with venlafaxine versus focused
attention with venlafaxine versus hypnosis plus a placebo versus focused attention plus a
placebo for reducing hot flashes.
III. To evaluate the effects of the four treatment arms on mood, sleep, hot flash
interference and menopause quality of life.
IV. To explore the role of expectancy and hypnotizability as moderators of the effect of
each of the four treatment arms in reducing hot flashes.
Outline: Patients are randomized to 1 of 4 intervention arms. Patients receive oral
venlafaxine or a placebo and practice hypnosis or focused attention.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care
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