Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Completed	Not specified	NCI	URCC-U2101 NCI-P01-0183, NCT00022074

Objectives

1. 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.
2. Compare quality of life, anxiety, and depression in patients treated with these regimens.

Entry 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

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

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

Expected Enrollment

A total of 408 patients (136 per arm) will be accrued for this study within 18 months.

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.

Pandya KJ, Morrow GR, Roscoe JA, et al.: Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet 366 (9488): 818-24, 2005 Sep 3-9.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

James P. Wilmot Cancer Center at University of Rochester Medical Center

Kishan Pandya, MD, Protocol chair		Ph: 585-275-9319 Email: kishan_pandya@urmc.rochester.edu

Registry Information
Official Title		Control of Vasomotor Symptoms in Women Treated for Breast Cancer
Trial Start Date		2001-07-13
Trial Completion Date		2005-06-30
Registered in ClinicalTrials.gov		NCT00022074
Date Submitted to PDQ		2001-06-07
Information Last Verified		2003-10-01