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

Hot Flashes Clinical Trial

Official title:

Evaluation of a Biobehavioral Intervention for Hot Flashes

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01000623
• Other study ID #: MC09C7
• Secondary ID: NCI-2009-0130309
• Status: Withdrawn
• Phase: N/A
• First received: October 19, 2009
• Last updated: December 15, 2016
• Start date: November 2009
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2015
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hot Flashes

Intervention

Drug:
• venlafaxine
Given orally
• placebo
Given orally

Procedure:
• hypnotherapy
Practice hypnosis
• mind-body intervention procedure
Practice focused attention

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hot flash score measured by hot flash diary data		Baseline	No
Primary	Hot flash severity measured by hot flash diary data		Baseline	No
Primary	Hot flash frequency measured by hot flash diary data		Baseline	No
Primary	Hot flash score measured by hot flash diary data		Daily during study, weeks 2-8	No
Primary	Hot flash severity measured by hot flash diary data		Daily during study, weeks 2-8	No
Primary	Hot flash frequency measured by hot flash diary data		Daily during study, weeks 2-8	No
Secondary	Side effects measured by CTCAE v 3.0 and patient reports		Baseline	Yes
Secondary	Side effects measured by CTCAE v 3.0 and patient reports		Once a week, weeks 2-8	No
Secondary	Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire		Baseline	No
Secondary	Mood measured by Profile of Mood States questionnaire		Baseline	No
Secondary	Menopause quality of life measured by MENQOL questionnaire		Baseline	No
Secondary	Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire		Baseline	No
Secondary	Sleep effects measured by Modified Medical Outcomes Sleep Scale questionnaire		Week 8	No
Secondary	Mood measured by Profile of Mood States questionnaire		Week 8	No
Secondary	Menopause quality of life measured by MENQOL questionnaire		Week 8	No
Secondary	Daily interference measured by Hot Flash Related Daily Interference Scale questionnaire		Week 8	No
Secondary	Evaluate the moderating effect of the expectations for the intervention to be effective and the ability of the person to be hypnotized		Week 5	No