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

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.

Intervention(s) in this Clinical Trial

• Drug: venlafaxine
  • Given orally
• Drug: placebo
  • Given orally
• Procedure: hypnotherapy
  • Practice hypnosis
• Procedure: mind-body intervention procedure
  • Practice focused attention

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm I
  • 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.
• Active Comparator: Arm II
  • 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.
• Active Comparator: Arm III
  • 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.
• Active Comparator: Arm IV
  • 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.

Primary Measures

• Hot flash score, frequency, and severity
  • Safety Issue?: No

Secondary Measures

• Side effects measured by CTCAE v 3.0 and patient reports
  • Safety Issue?: Yes
• Sleep, mood, menopause, and daily interference
  • Safety Issue?: No
• 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
    Safety Issue?: No

• 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)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Mayo Clinic Other

Overall Clinical Trial Officials and Contacts

Debra L. Barton, R.N., Ph.D. Principal Investigator Mayo Clinic  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01000623

Study ID Number: MC09C7

ClinicalTrials.gov Identifier: NCT01000623

Health Authority: United States: Federal Government