Clinical trial NCT01000623: Venlafaxine and Hypnosis or Focused Attention in Treating Patients with Hot Flashes
Official title: Evaluation of a Biobehavioral Intervention for Hot Flashes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hot Flashes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-10-23
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Hot flash score measured by hot flash diary data
timeFrame: Baseline
measure: Hot flash severity measured by hot flash diary data
timeFrame: Baseline
measure: Hot flash frequency measured by hot flash diary data
timeFrame: Baseline
measure: Hot flash score measured by hot flash diary data
timeFrame: Daily during study, weeks 2-8
measure: Hot flash severity measured by hot flash diary data
timeFrame: Daily during study, weeks 2-8
measure: Hot flash frequency measured by hot flash diary data
timeFrame: Daily during study, weeks 2-8
Secondary outcomes:
measure: Side effects measured by CTCAE v 3.0 and patient reports
timeFrame: Baseline
measure: Side effects measured by CTCAE v 3.0 and patient reports
timeFrame: Once a week, weeks 2-8
measure: Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
timeFrame: Baseline
measure: Mood measured by Profile of Mood States questionnaire
timeFrame: Baseline
measure: Menopause quality of life measured by MENQOL questionnaire
timeFrame: Baseline
measure: Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire
timeFrame: Baseline
measure: Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
timeFrame: Week 8
measure: Mood measured by Profile of Mood States questionnaire
timeFrame: Week 8
measure: Menopause quality of life measured by MENQOL questionnaire
timeFrame: Week 8
measure: Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire
timeFrame: Week 8
measure: Evaluate the moderating effect of the expectations for the intervention to be effective and the ability of the person to be hypnotized
timeFrame: Week 5
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Debra L. Barton, R.N., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: