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Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
This study has been completed.
Study NCT00022074   Information provided by National Cancer Institute (NCI)
First Received: August 10, 2001   Last Updated: August 19, 2009   History of Changes

August 10, 2001
August 19, 2009
July 2001
June 2005   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00022074 on ClinicalTrials.gov Archive Site
 
 
 
Gabapentin For the Control of Hot Flashes in Women With Breast Cancer
Control of Vasomotor Symptoms in Women Treated for Breast Cancer

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.

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.

 
Interventional
Supportive Care, Randomized, Open Label, Placebo Control
  • Anxiety Disorder
  • Breast Cancer
  • Depression
  • Hot Flashes
  • Drug: gabapentin
  • Procedure: quality-of-life assessment
 
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.
 
Completed
 
 
June 2005   (final data collection date for primary outcome measure)

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
Female
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00022074
 
CDR0000068780, URCC-U2101, NCI-P01-0183
James P. Wilmot Cancer Center
National Cancer Institute (NCI)
Study Chair: Kishan J. Pandya, MD James P. Wilmot Cancer Center
National Cancer Institute (NCI)
October 2003

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