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.

Condition	Treatment or Intervention	Phase
Breast Cancer Hot Flashes	Drug: gabapentin  Procedure: complications of therapy assessment/management  Procedure: hot flashes attenuation  Procedure: menopausal symptoms attenuation  Procedure: supportive care/therapy	Phase III

Further Study Details: 

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 about taking hormonal therapy due to a fear of developing breast cancer.
• Compare adverse events in patients treated with these regimens.
• Correlate a reduction in hot flash scores with improvement in quality of life and related outcomes in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to duration of hot flash symptoms (< 9 months vs ≥ 9 months), average frequency of hot flashes per day (2-3 vs 4-9 vs ≥ 10), and antidepressant currently being used (venlafaxine vs paroxetine vs other). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients continue to receive the same antidepressant (as before study entry) on weeks 1-5. During weeks 2-5, patients also receive oral gabapentin once daily on days 8-10, twice daily on days 11-13, and then three times daily on days 14-35 in the absence of unacceptable toxicity.
• Arm II: Patients receive gabapentin as in arm I. Patients are tapered off their antidepressant over 7-10 days and remain on gabapentin alone (per arm I schedule). Patients in both arms complete a hot flash diary at baseline and then daily during study treatment.

Quality of life is assessed at baseline and then weekly during study treatment.

PROJECTED ACCRUAL: A total of 110 patients (55 per treatment arm) will be accrued for this study within 2 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

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

Radiotherapy

• Not specified

Surgery

• Not specified

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

Alabama
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36607,  United States; Recruiting
Arizona
      CCOP - Mayo Clinic Scottsdale Oncology Program, Scottsdale,  Arizona,  85259-5404,  United States; Recruiting
District of Columbia
      MBCCOP - Howard University Cancer Center, Washington,  District of Columbia,  20060,  United States; Recruiting
Florida
      Mayo Clinic - Jacksonville, Jacksonville,  Florida,  32224,  United States; Recruiting
Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States; Recruiting
Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States; Recruiting
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States; Recruiting
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61615-7828,  United States; Recruiting
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States; Recruiting
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States; Recruiting
      Siouxland Hematology-Oncology, Sioux City,  Iowa,  51101-1733,  United States; Recruiting
Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States; Recruiting
Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States; Recruiting
Michigan
      CCOP - Michigan Cancer Research Consortium, Ann Arbor,  Michigan,  48106,  United States; Recruiting
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States; Recruiting
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States; Recruiting
      Coborn Cancer Center, Saint Cloud,  Minnesota,  56303,  United States; Recruiting
      Mayo Clinic Cancer Center, Rochester,  Minnesota,  55905,  United States; Recruiting
      Virginia Piper Cancer Institute at Abbott-Northwestern Hospital, Minneapolis,  Minnesota,  55407,  United States; Recruiting
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68106,  United States; Recruiting
North Dakota
      Altru Cancer Center, Grand Forks,  North Dakota,  58201,  United States; Recruiting
      CCOP - Merit Care Hospital, Fargo,  North Dakota,  58122,  United States; Recruiting
      Medcenter One Health System, Bismarck,  North Dakota,  58501-5505,  United States; Recruiting
Ohio
      CCOP - Dayton, Dayton,  Ohio,  45429,  United States; Recruiting
      CCOP - Toledo Community Hospital, Toledo,  Ohio,  43623-3456,  United States; Recruiting
Oklahoma
      CCOP - Oklahoma, Tulsa,  Oklahoma,  74136,  United States; Recruiting
Pennsylvania
      Allegheny General Hospital, Pittsburgh,  Pennsylvania,  15212-4772,  United States; Recruiting
      CCOP - Geisinger Clinic and Medical Center, Danville,  Pennsylvania,  17822-2001,  United States; Recruiting
South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States; Recruiting
South Dakota
      CCOP - Sioux Community Cancer Consortium, Sioux Falls,  South Dakota,  57104,  United States; Recruiting
      Rapid City Regional Hospital, Rapid City,  South Dakota,  57709,  United States; Recruiting
Wisconsin
      CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay,  Wisconsin,  54301,  United States; Recruiting
Canada, Saskatchewan
      Allan Blair Cancer Centre at Pasqua Hospital, Regina,  Saskatchewan,  S4T 7T1,  Canada; Recruiting

Study chairs or principal investigators

Charles L. Loprinzi, MD,  Study Chair,  Mayo Clinic Cancer Center   
Debra Barton, RN, PhD,  Mayo Clinic Cancer Center   

Study ID Numbers:  CDR0000374993; NCCTG-N03C5; NCT00087399
Record last reviewed:  December 2004
Last Updated:  April 4, 2005
Record first received:  July 8, 2004
ClinicalTrials.gov Identifier:  NCT00087399
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08