Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Gabapentin may be effective in relieving hot flashes in women who have had breast cancer or who have concerns about taking hormone therapy to treat hot flashes. It is not yet known whether gabapentin is more effective with or without antidepressants in treating hot flashes.

PURPOSE: This randomized phase III trial is studying gabapentin and antidepressants to see how well they work compared to antidepressants alone in treating hot flashes in women who have had breast cancer or who have concerns about taking hormones to treat hot flashes.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance for Clinical Trials in Oncology
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antidepressive Agents; Gabapentin; gamma-Aminobutyric Acid

Criteria

DISEASE CHARACTERISTICS:

• History of breast cancer OR a concern about taking hormonal therapy due to a fear of developing breast cancer

• Experiencing bothersome hot flashes, defined as patient-reported occurrence ≥ 14 times per week AND sufficiently severe to prompt desire for additional therapeutic intervention despite current use of an antidepressant

• Currently (≥ 2 weeks) being treated with a stable dose of an antidepressant

• No monoamine oxidase inhibitors or tricyclics

• No current evidence of malignant disease

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Performance status

• ECOG 0-1

Life expectancy

• At least 6 months

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Chemotherapy

• More than 4 weeks since prior antineoplastic chemotherapy

• No concurrent antineoplastic chemotherapy

Endocrine therapy

• More than 4 weeks since prior androgens, estrogens, or progestational agents

• More than 2 weeks since prior dehydroepiandrosterone (DHEA) for treatment of hot flashes

• No concurrent androgens, estrogens, or progestational agents, including oral contraceptives

• No concurrent DHEA for treatment of hot flashes

• Concurrent tamoxifen, raloxifene, or aromatase inhibitor therapy allowed if on a stable dose for at least 4 weeks prior to study entry and during study treatment

Other

• No prior gabapentin

• More than 2 weeks since other prior treatment for hot flashes (e.g., clonidine or Bellergal-S®)

• Concurrent vitamin E or soy supplements allowed if on a stable dose for at least 1 month prior to study entry and during study treatment

• No other concurrent treatment for hot flashes (e.g., clonidine or Bellergal-S®)

• No other concurrent antidepressants