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

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.

Study Overview

• Status: Withdrawn
• Conditions: Hot Flashes
• Intervention / Treatment: Drug: placebo; Drug: venlafaxine; Procedure: hypnotherapy; Procedure: mind-body intervention procedure

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: venlafaxine; Given orally; Other Names: Effexor; VNF; Procedure: hypnotherapy; Practice hypnosis; Other Names: hypnosis
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.	Drug: venlafaxine; Given orally; Other Names: Effexor; VNF; Procedure: mind-body intervention procedure; Practice focused attention; Other Names: mind-body interventions
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.	Drug: placebo; Given orally; Other Names: PLCB; Procedure: hypnotherapy; Practice hypnosis; Other Names: hypnosis
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.	Drug: placebo; Given orally; Other Names: PLCB; Procedure: mind-body intervention procedure; Practice focused attention; Other Names: mind-body interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hot flash score measured by hot flash diary data	Baseline
Hot flash severity measured by hot flash diary data	Baseline
Hot flash frequency measured by hot flash diary data	Baseline
Hot flash score measured by hot flash diary data	Daily during study, weeks 2-8
Hot flash severity measured by hot flash diary data	Daily during study, weeks 2-8
Hot flash frequency measured by hot flash diary data	Daily during study, weeks 2-8

Secondary Outcome Measures

Outcome Measure	Time Frame
Side effects measured by CTCAE v 3.0 and patient reports	Baseline
Side effects measured by CTCAE v 3.0 and patient reports	Once a week, weeks 2-8
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire	Baseline
Mood measured by Profile of Mood States questionnaire	Baseline
Menopause quality of life measured by MENQOL questionnaire	Baseline
Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire	Baseline
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire	Week 8
Mood measured by Profile of Mood States questionnaire	Week 8
Menopause quality of life measured by MENQOL questionnaire	Week 8
Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire	Week 8
Evaluate the moderating effect of the expectations for the intervention to be effective and the ability of the person to be hypnotized	Week 5

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Debra L. Barton, R.N., Ph.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 19, 2009
• First Submitted That Met QC Criteria: October 22, 2009
• First Posted (Estimate): October 23, 2009

Study Record Updates

• Last Update Posted (Estimate): December 16, 2016
• Last Update Submitted That Met QC Criteria: December 15, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hot Flashes; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: MC09C7 (Other Identifier: Mayo Clinic Cancer Center); NCI-2009-01303 (Registry Identifier: NCI's CTRO); 09-003233 (Other Identifier: Mayo Clinic IRB)