Overview

This trial is active, not recruiting.

Condition hot flashes
Treatments venlafaxine, placebo, hypnotherapy, mind-body intervention procedure
Sponsor Mayo Clinic
Collaborator National Cancer Institute (NCI)
Start date November 2009
End date March 2017
Trial size 100 participants
Trial identifier NCT01000623, 09-003233, MC09C7, NCI-2009-01303

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Experimental)
Patients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8.
venlafaxine Effexor
Given orally
hypnotherapy hypnosis
Practice hypnosis
(Active Comparator)
Patients receive oral venlafaxine once or twice daily in weeks 2-8. Patients see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8.
venlafaxine Effexor
Given orally
mind-body intervention procedure mind-body interventions
Practice focused attention
(Active Comparator)
Patients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn hypnosis in weeks 2-5. Patients continue hypnosis at home in weeks 6-8.
placebo PLCB
Given orally
hypnotherapy hypnosis
Practice hypnosis
(Active Comparator)
Patients receive oral placebo once or twice daily in weeks 2-8. Patient see a therapist once a week to learn focused attention in weeks 2-5. Patients continue focused attention at home in weeks 6-8.
placebo PLCB
Given orally
mind-body intervention procedure mind-body interventions
Practice focused attention

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 18 years old.

Inclusion - Women with a history of breast cancer (currently without malignant disease) or women who have no history of breast cancer but who wish to avoid estrogen due to a perceived increased risk of breast cancer - Women over the age of 18 who are postmenopausal and wish to avoid hormonal therapy to treat menopausal symptoms - Postmenopausal as defined by: 1. no menstrual period in the past 12 months; 2. no menstrual period in the past 6 months and an FSH level greater than 40; or 3. women who have had a bilateral oophorectomy - If women have had a hysterectomy and still have their ovaries, they must meet the FSH criteria described above - Note: We are excluding women of childbearing potential as this is a pilot trial and allowing women of childbearing potential with hot flashes to participate would introduce a hormonal heterogeneous population that would confound the ability to answer the research question - Bothersome hot flashes (defined by their occurrence >= 28 times per week [about 4 per day]) and of sufficient severity to make the patient desire therapeutic intervention - Presence of hot flashes for >=1 month prior to study entry - Life expectancy >= 6 months - ECOG Performance Status (PS) 0 or 1 - Possession of a CD/DVD player or ability to play a CD Exclusion - Any of the following current (=< last 4 weeks) or planned therapies: antineoplastic chemotherapy, androgens, estrogens, progestational agents, other herbal supplements, including soy (herbal teas from a store are allowed), or Warfarin (1 mg of daily warfarin is allowed for central line patency) - Tamoxifen, raloxifene, or aromatase inhibitors are allowed, but the patient must have been on a constant dose for >= 4 weeks and ust not be expected to stop the medication during the study period - History of allergic or other adverse reaction to venlafaxine or SSRI's - Current or planned use of other agents for treating hot flashes - Use of venlafaxine or hypnosis in the past 6 months - Diagnosis of/problems with chronic diarrhea or history of bowel obstruction or esophageal stricture - Pregnant women or nursing women - Current or planned use of any type of antidepressants - Diagnosis of major depressive episode, acute anxiety disorder, liver or kidney dysfunction (defined by SGOT and creatinine levels 1.5 x upper limit of normal) as listed in the patient's medical history in the chart within the past year and by self report - Uncontrolled hypertension (defined as 3 consecutive readings over the past year of over 160 systolic, and over 100 diastolic)

Additional Information

Official title Evaluation of a Biobehavioral Intervention for Hot Flashes
Principal investigator Debra L. Barton, R.N., Ph.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.