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

Primary Purpose

Hot Flashes

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
venlafaxine
placebo
hypnotherapy
mind-body intervention procedure
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hot Flashes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Arm I

Arm II

Arm III

Arm IV

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Hot flash score measured by hot flash diary data
Hot flash severity measured by hot flash diary data
Hot flash frequency measured by hot flash diary data
Hot flash score measured by hot flash diary data
Hot flash severity measured by hot flash diary data
Hot flash frequency measured by hot flash diary data

Secondary Outcome Measures

Side effects measured by CTCAE v 3.0 and patient reports
Side effects measured by CTCAE v 3.0 and patient reports
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
Mood measured by Profile of Mood States questionnaire
Menopause quality of life measured by MENQOL questionnaire
Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
Mood measured by Profile of Mood States questionnaire
Menopause quality of life measured by MENQOL questionnaire
Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire
Evaluate the moderating effect of the expectations for the intervention to be effective and the ability of the person to be hypnotized

Full Information

First Posted
October 19, 2009
Last Updated
December 15, 2016
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01000623
Brief Title
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

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Withdrawn
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm III
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Arm IV
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
venlafaxine
Other Intervention Name(s)
Effexor, VNF
Intervention Description
Given orally
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
PLCB
Intervention Description
Given orally
Intervention Type
Procedure
Intervention Name(s)
hypnotherapy
Other Intervention Name(s)
hypnosis
Intervention Description
Practice hypnosis
Intervention Type
Procedure
Intervention Name(s)
mind-body intervention procedure
Other Intervention Name(s)
mind-body interventions
Intervention Description
Practice focused attention
Primary Outcome Measure Information:
Title
Hot flash score measured by hot flash diary data
Time Frame
Baseline
Title
Hot flash severity measured by hot flash diary data
Time Frame
Baseline
Title
Hot flash frequency measured by hot flash diary data
Time Frame
Baseline
Title
Hot flash score measured by hot flash diary data
Time Frame
Daily during study, weeks 2-8
Title
Hot flash severity measured by hot flash diary data
Time Frame
Daily during study, weeks 2-8
Title
Hot flash frequency measured by hot flash diary data
Time Frame
Daily during study, weeks 2-8
Secondary Outcome Measure Information:
Title
Side effects measured by CTCAE v 3.0 and patient reports
Time Frame
Baseline
Title
Side effects measured by CTCAE v 3.0 and patient reports
Time Frame
Once a week, weeks 2-8
Title
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
Time Frame
Baseline
Title
Mood measured by Profile of Mood States questionnaire
Time Frame
Baseline
Title
Menopause quality of life measured by MENQOL questionnaire
Time Frame
Baseline
Title
Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire
Time Frame
Baseline
Title
Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire
Time Frame
Week 8
Title
Mood measured by Profile of Mood States questionnaire
Time Frame
Week 8
Title
Menopause quality of life measured by MENQOL questionnaire
Time Frame
Week 8
Title
Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire
Time Frame
Week 8
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: no menstrual period in the past 12 months; no menstrual period in the past 6 months and an FSH level greater than 40; or 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra L. Barton, R.N., Ph.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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

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