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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01000623
Recruitment Status : Withdrawn
First Posted : October 23, 2009
Last Update Posted : December 16, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

Tracking Information
First Submitted Date  ICMJE October 19, 2009
First Posted Date  ICMJE October 23, 2009
Last Update Posted Date December 16, 2016
Study Start Date  ICMJE November 2009
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • Hot flash score measured by hot flash diary data [ Time Frame: Baseline ]
  • Hot flash severity measured by hot flash diary data [ Time Frame: Baseline ]
  • Hot flash frequency measured by hot flash diary data [ Time Frame: Baseline ]
  • Hot flash score measured by hot flash diary data [ Time Frame: Daily during study, weeks 2-8 ]
  • Hot flash severity measured by hot flash diary data [ Time Frame: Daily during study, weeks 2-8 ]
  • Hot flash frequency measured by hot flash diary data [ Time Frame: Daily during study, weeks 2-8 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
Hot flash score, frequency, and severity
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • Side effects measured by CTCAE v 3.0 and patient reports [ Time Frame: Baseline ]
  • Side effects measured by CTCAE v 3.0 and patient reports [ Time Frame: Once a week, weeks 2-8 ]
  • Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire [ Time Frame: Baseline ]
  • Mood measured by Profile of Mood States questionnaire [ Time Frame: Baseline ]
  • Menopause quality of life measured by MENQOL questionnaire [ Time Frame: Baseline ]
  • Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire [ Time Frame: Baseline ]
  • Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire [ Time Frame: Week 8 ]
  • Mood measured by Profile of Mood States questionnaire [ Time Frame: Week 8 ]
  • Menopause quality of life measured by MENQOL questionnaire [ Time Frame: Week 8 ]
  • Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire [ Time Frame: Week 8 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2009)
  • Side effects measured by CTCAE v 3.0 and patient reports
  • Sleep, mood, menopause, and daily interference
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Venlafaxine and Hypnosis or Focused Attention In Treating Patients With Hot Flashes
Official Title  ICMJE Evaluation of a Biobehavioral Intervention for Hot Flashes
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Supportive Care
Condition  ICMJE Hot Flashes
Intervention  ICMJE
  • Drug: venlafaxine
    Given orally
    Other Names:
    • Effexor
    • VNF
  • Drug: placebo
    Given orally
    Other Name: PLCB
  • Procedure: hypnotherapy
    Practice hypnosis
    Other Name: hypnosis
  • Procedure: mind-body intervention procedure
    Practice focused attention
    Other Name: mind-body interventions
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: venlafaxine
    • Procedure: hypnotherapy
  • 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.
    Interventions:
    • Drug: venlafaxine
    • Procedure: mind-body intervention procedure
  • 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.
    Interventions:
    • Drug: placebo
    • Procedure: hypnotherapy
  • 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.
    Interventions:
    • Drug: placebo
    • Procedure: mind-body intervention procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 15, 2016)
0
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2009)
100
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01000623
Other Study ID Numbers  ICMJE MC09C7
NCI-2009-01303 ( Registry Identifier: NCI's CTRO )
09-003233 ( Other Identifier: Mayo Clinic IRB )
MC09C7 ( Other Identifier: Mayo Clinic Cancer Center )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Debra L. Barton, R.N., Ph.D. Mayo Clinic
PRS Account Mayo Clinic
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP