Venlafaxine and Hypnosis or Focused Attention In Treating Patients With Hot Flashes - Full Text View

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:

Drug Information available for: Venlafaxine Venlafaxine hydrochloride

U.S. FDA Resources

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 2014
Estimated Primary Completion Date:	July 2013 (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

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

Locations

United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Mayo Clinic Clinical Trials Office 507-538-7623
Principal Investigator: Debra L. Barton, R.N., Ph.D.

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

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:	November 5, 2012
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 May 21, 2013