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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
71
Mayo Clinic
Rochester, Minnesota, United States
Hot flash score measured by hot flash diary data
Time frame: Baseline
Hot flash severity measured by hot flash diary data
Time frame: Baseline
Hot flash frequency measured by hot flash diary data
Time frame: Baseline
Hot flash score measured by hot flash diary data
Time frame: Daily during study, weeks 2-8
Hot flash severity measured by hot flash diary data
Time frame: Daily during study, weeks 2-8
Hot flash frequency measured by hot flash diary data
Time frame: Daily during study, weeks 2-8
Side effects measured by CTCAE v 3.0 and patient reports
Time frame: Baseline
Side effects measured by CTCAE v 3.0 and patient reports
Time frame: Once a week, weeks 2-8
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
Time frame: Baseline
Mood measured by Profile of Mood States questionnaire
Time frame: Baseline
Menopause quality of life measured by MENQOL questionnaire
Time frame: Baseline
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Practice focused attention
Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire
Time frame: Baseline
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
Time frame: Week 8
Mood measured by Profile of Mood States questionnaire
Time frame: Week 8
Menopause quality of life measured by MENQOL questionnaire
Time frame: Week 8
Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire
Time frame: Week 8
Evaluate the moderating effect of the expectations for the intervention to be effective and the ability of the person to be hypnotized
Time frame: Week 5