Phase III Comparison of Depomedroxyprogesterone Acetate (DPROV) to Venlafaxine for Managing Hot Flashes

Inclusion Criteria

DISEASE CHARACTERISTICS:

- History of breast cancer, ductal carcinoma in situ, or lobular carcinoma in situ
(currently without evidence of malignant disease) OR

- Concerns about taking estrogen for fear of breast cancer

- Bothersome hot flashes, defined as occurrence at least 14 times per week and of
sufficient severity as to make patient desire therapeutic intervention

- Presence of hot flashes for at least 1 month

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- ECOG 0-1

Life expectancy:

- At least 6 months

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Cardiovascular:

- No prior thromboembolic disease

- No uncontrolled hypertension (persistent diastolic blood pressure greater than 95 mm
Hg and/or systolic blood pressure greater than 160 mm Hg)

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- More than 4 weeks since prior antineoplastic chemotherapy

- No concurrent antineoplastic chemotherapy unless clinically appropriate

Endocrine therapy:

- More than 4 weeks since prior androgen or estrogen therapy

- More than 3 months since prior progesterone as part of hormone replacement therapy

- At least 1 year since any other progesterone therapy (including megestrol)

- No concurrent androgen, estrogen, or progestational agents unless clinically
appropriate

- Concurrent tamoxifen, raloxifene, or aromatase inhibitors are allowed if started more
than 4 weeks ago and continuation for more than 5 weeks is planned

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- More than 2 weeks since prior agents for treatment of hot flashes (e.g., clonidine,
Bellergal-S, or vitamin E of more than 400 mg per day)

- More than 1 year since prior antidepressants (including Hypericum perforatum [St
John's Wort])

- No other concurrent antidepressants or monoamine oxidase inhibitors

- No other concurrent agents for treatment of hot flashes (e.g. clonidine, Bellergal-S,
or vitamin E of more than 400 mg per day)