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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01000623
First received: October 19, 2009
Last updated: March 24, 2014
Last verified: March 2014

October 19, 2009
March 24, 2014
November 2009
September 2014   (final data collection date for primary outcome measure)
Hot flash score, frequency, and severity [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01000623 on ClinicalTrials.gov Archive Site
  • Side effects measured by CTCAE v 3.0 and patient reports [ Designated as safety issue: Yes ]
  • Sleep, mood, menopause, and daily interference [ Designated as 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Hot Flashes
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
January 2015
September 2014   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01000623
MC09C7, NCI-2009-01303, 09-003233, MC09C7
Yes
Debra L. Barton, R.N., Ph.D., Mayo Clinic Cancer Center
Mayo Clinic
National Cancer Institute (NCI)
Principal Investigator: Debra L. Barton, R.N., Ph.D. Mayo Clinic
Mayo Clinic
March 2014

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