Status:
COMPLETED
Gabapentin With or Without Antidepressants in Treating Hot Flashes in Women Who Have Had Breast Cancer or Have Concerns About Taking Hormone Therapy
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Hot Flashes
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 ...
Detailed Description
OBJECTIVES: * Compare the efficacy of gabapentin with vs without an antidepressant, as measured by the frequency and intensity of hot flashes, in patients with a history of breast cancer or a concern...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT00087399
Start Date
November 1 2004
End Date
April 1 2007
Last Update
July 14 2016
Active Locations (162)
Enter a location and click search to find clinical trials sorted by distance.
1
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224-9980
3
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
4
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507