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Evaluation of a Biobehavioral Intervention for Hot Flashes

18 Years
Open (Enrolling)
Hot Flashes

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Trial Information

Evaluation of a Biobehavioral Intervention for Hot Flashes


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.

Inclusion Criteria


- 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

- Uncontrolled hypertension (defined as 3 consecutive readings over the past year of
over 160 systolic, and over 100 diastolic)

Type of Study:


Study Design:

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

Outcome Measure:

Hot flash score, frequency, and severity

Safety Issue:


Principal Investigator

Debra L. Barton, R.N., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

November 2009

Completion Date:

January 2014

Related Keywords:

  • Hot Flashes
  • Hot Flashes



Mayo Clinic Rochester, Minnesota  55905