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

Breast Cancer Clinical Trial

Official title:

Control of Vasomotor Symptoms in Women Treated for Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022074
• Other study ID #: CDR0000068780
• Secondary ID: URCC-U2101NCI-P0
• Status: Completed
• Phase: N/A
• First received: August 10, 2001
• Last updated: October 13, 2015
• Start date: July 2001
• Est. completion date: June 2005

Study information

• Verified date: October 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 120 Years

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

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Breast Cancer
• Breast Neoplasms
• Depression
• Hot Flashes

Intervention

Drug:
• gabapentin

Procedure:
• quality-of-life assessment

Locations

Country	Name	City	State
United States	CCOP - Columbus	Columbus	Ohio
United States	CCOP - Dayton	Dayton	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	CCOP - Colorado Cancer Research Program, Incorporated	Denver	Colorado
United States	CCOP - Northern New Jersey	Hackensack	New Jersey
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	CCOP - Marshfield Medical Research and Education Foundation	Marshfield	Wisconsin
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	CCOP - Greater Phoenix	Phoenix	Arizona
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	CCOP - Scottsdale Oncology Program	Scottsdale	Arizona
United States	CCOP - Virginia Mason Research Center	Seattle	Washington
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	CCOP - Northwest	Tacoma	Washington
United States	CCOP - Wichita	Wichita	Kansas
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Gary Morrow	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pandya KJ, Morrow GR, Roscoe JA, Zhao H, Hickok JT, Pajon E, Sweeney TJ, Banerjee TK, Flynn PJ. Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet. 2005 Sep 3-9;366(9488):818-24. — View Citation