Evaluation of a Biobehavioral Intervention for Hot Flashes

Inclusion 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)