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

Tracking Information

First Received Date ^ICMJE

August 10, 2001

Last Updated Date

August 19, 2009

Start Date ^ICMJE

July 2001

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00022074 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Control of Vasomotor Symptoms in Women Treated for Breast Cancer

Brief 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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Supportive Care, Randomized, Open Label, Placebo Control

Condition ^ICMJE

Anxiety Disorder
Breast Cancer
Depression
Hot Flashes

Intervention ^ICMJE

Drug: gabapentin
Procedure: quality-of-life assessment

Study Arms / Comparison Groups

Publications *

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

June 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00022074

Responsible Party

Study ID Numbers ^ICMJE

CDR0000068780, URCC-U2101, NCI-P01-0183

Study Sponsor ^ICMJE

James P. Wilmot Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Kishan J. Pandya, MD

James P. Wilmot Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP