Clinical Trial: Venlafaxine and Hypnosis or Focused Attention In Treating Patients With Hot Flashes

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Evaluation of a Biobehavioral Intervention for Hot Flashes

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Mayo Clinic

Current Primary Outcome:

  • 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 ]


Original Primary Outcome: Hot flash score, frequency, and severity

Current Secondary Outcome:

  • 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 ]
  • 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 ]


Original Secondary Outcome:

  • Side effects measured by CTCAE v 3.0 and patient reports
  • Sleep, mood, menopause, and daily interference
  • 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 ]


Information By: Mayo Clinic

Dates:
Date Received: October 19, 2009
Date Started: November 2009
Date Completion:
Last Updated: December 15, 2016
Last Verified: April 2016