Venlafaxine and Hypnosis or Focused Attention in Treating Patients with Hot Flashes

NCT ID: NCT01000623

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2015-09-08

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.

Conditions

Hot Flashes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

venlafaxine

Intervention Type: DRUG

Given orally

hypnotherapy

Intervention Type: PROCEDURE

Practice hypnosis

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.

Group Type: ACTIVE_COMPARATOR

venlafaxine

Intervention Type: DRUG

Given orally

mind-body intervention procedure

Intervention Type: PROCEDURE

Practice focused attention

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.

Group Type: ACTIVE_COMPARATOR

placebo

Intervention Type: DRUG

Given orally

hypnotherapy

Intervention Type: PROCEDURE

Practice hypnosis

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.

Group Type: ACTIVE_COMPARATOR

placebo

Intervention Type: DRUG

Given orally

mind-body intervention procedure

Intervention Type: PROCEDURE

Practice focused attention

Interventions

venlafaxine

Given orally

Intervention Type: DRUG

placebo

Given orally

Intervention Type: DRUG

hypnotherapy

Practice hypnosis

Intervention Type: PROCEDURE

mind-body intervention procedure

Practice focused attention

Intervention Type: PROCEDURE

Other Intervention Names

Effexor; VNF; PLCB; hypnosis; mind-body interventions

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debra L. Barton, R.N., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

NCI-2009-01303

Identifier Type: REGISTRY

Identifier Source: secondary_id

09-003233

Identifier Type: OTHER

Identifier Source: secondary_id

MC09C7

Identifier Type: OTHER

Identifier Source: secondary_id

MC09C7

Identifier Type: -

Identifier Source: org_study_id