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

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gary Morrow
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gabapentin

Criteria

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