Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Gabapentin For the Control of Hot Flashes in Women With Breast Cancer

Summary: RATIONALE: Gabapentin may be effective for the control of hot flashes. It is not yet known if gabapentin is effective in treating hot flashes.
  PURPOSE: Randomized clinical trial to study the effectiveness of gabapentin in controlling hot flashes in women who have breast cancer.

Detailed description: OBJECTIVES:
  -  Compare the effectiveness and side effects of 2 different doses of gabapentin vs placebo for the control of hot flashes and other vasomotor symptoms in women with breast cancer.
  -  Compare quality of life, anxiety, and depression in patients treated with these regimens.
  OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and duration of hot flash symptoms (less than 9 months vs 9 or more months). Patients are randomized to 1 of 3 arms.
  -  Arm I: Patients receive oral placebo 3 times a day.
  -  Arm II: Patients receive oral gabapentin at a low dose 3 times a day.
  -  Arm III: Patients receive oral gabapentin as in arm II for 3 days and then at a high dose 3 times a day.
  Treatment on all arms continues for 8 weeks in the absence of unacceptable toxicity. After week 8, patients may receive open-label gabapentin at the discretion of their physicians.
  Hot flashes are assessed at baseline and then during weeks 3 and 7 of the study.
  Quality of life, anxiety, and depression are assessed at baseline and then at weeks 4 and 8.
  Patients are followed at week 12.
  PROJECTED ACCRUAL: A total of 408 patients (136 per arm) will be accrued for this study within 18 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of breast cancer
  -  Experiencing 2 or more hot flashes per day for at least 1 week
  -  Hormone receptor status:
  -  Not specified
  PATIENT CHARACTERISTICS:
  Age:
  -  Not specified
  Sex:
  -  Female
  Menopausal status:
  -  Not specified
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Bilirubin normal
  -  SGOT no greater than 2 times upper limit of normal (ULN)
  Renal:
  -  Creatinine no greater than 1.25 times ULN
  Cardiovascular:
  -  No coronary insufficiency
  -  No myocardial infarction within the past 3 months
  -  No symptomatic cardiac disease
  -  No peripheral vascular disease
  -  No cerebrovascular disease or stroke
  -  No syncope or symptomatic hypotension
  Other:
  -  No history of allergic or other adverse reaction to gabapentin
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception during and for 1 week after study
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  Not specified
  Chemotherapy
  -  Not specified
  Endocrine therapy
  -  Not specified
  Radiotherapy
  -  Not specified
  Surgery
  -  Not specified
  Other
  -  No other concurrent anticonvulsant medication
  -  No concurrent clonidine or venlafaxine

Relevance to patient case: not relevant