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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionAnxiety Disorder
Breast Cancer
Depression
Hot Flashes
InterventionDrug: gabapentin
Procedure: quality-of-life assessment
PhaseN/A
SponsorGary Morrow
Responsible PartyUniversity of Rochester
ClinicalTrials.gov IdentifierNCT00022074
First ReceivedAugust 10, 2001
Last UpdatedMarch 4, 2013
Last verifiedMarch 2013

Tracking Information[ + expand ][ + ]

First Received DateAugust 10, 2001
Last Updated DateMarch 4, 2013
Start DateJuly 2001
Estimated Primary Completion DateJune 2005
Current Primary Outcome MeasuresNot Provided
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleGabapentin For the Control of Hot Flashes in Women With Breast Cancer
Official TitleControl 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 TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Condition
  • Anxiety Disorder
  • Breast Cancer
  • Depression
  • Hot Flashes
InterventionDrug: gabapentin
Procedure: quality-of-life assessment
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated EnrollmentNot Provided
Estimated Completion DateJune 2005
Estimated Primary Completion DateJune 2005
Eligibility 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
GenderFemale
AgesN/A
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00022074
Other Study ID NumbersCDR0000068780
Has Data Monitoring CommitteeNot Provided
Information Provided ByUniversity of Rochester
Study SponsorGary Morrow
CollaboratorsNational Cancer Institute (NCI)
Investigators Study Chair: Kishan J. Pandya, MD James P. Wilmot Cancer Center
Verification DateMarch 2013

Locations[ + expand ][ + ]

MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
CCOP - Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
CCOP - Central Illinois
Decatur, Illinois, United States, 62526
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, United States, 13217
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
CCOP - Columbus
Columbus, Ohio, United States, 43206
CCOP - Dayton
Dayton, Ohio, United States, 45429
CCOP - Virginia Mason Research Center
Seattle, Washington, United States, 98101
CCOP - Northwest
Tacoma, Washington, United States, 98405-0986
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States, 54449