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
  Purpose

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.


Condition Intervention
Hot Flashes
Drug: venlafaxine
Drug: placebo
Procedure: hypnotherapy
Procedure: mind-body intervention procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Evaluation of a Biobehavioral Intervention for Hot Flashes

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Hot flash score, frequency, and severity [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: November 2009
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned 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.
Drug: venlafaxine
Given orally
Other Names:
  • Effexor
  • VNF
Procedure: hypnotherapy
Practice hypnosis
Other Name: 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 Name: 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 Name: PLCB
Procedure: hypnotherapy
Practice hypnosis
Other Name: 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 Name: PLCB
Procedure: mind-body intervention procedure
Practice focused attention
Other Name: mind-body interventions

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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:

    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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000623

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Debra L. Barton, R.N., Ph.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Debra L. Barton, R.N., Ph.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT01000623     History of Changes
Other Study ID Numbers: MC09C7, NCI-2009-01303, 09-003233, MC09C7
Study First Received: October 19, 2009
Last Updated: March 24, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Venlafaxine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014