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Control of Vasomotor Symptoms in Women Treated for Breast Cancer


N/A
N/A
N/A
Not Enrolling
Female
Anxiety Disorder, Breast Cancer, Depression, Hot Flashes

Thank you

Trial Information

Control of Vasomotor Symptoms in Women Treated for 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.

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Kishan J. Pandya, MD

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068780

NCT ID:

NCT00022074

Start Date:

July 2001

Completion Date:

June 2005

Related Keywords:

  • Anxiety Disorder
  • Breast Cancer
  • Depression
  • Hot Flashes
  • stage I breast cancer
  • stage II breast cancer
  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • anxiety disorder
  • depression
  • hot flashes
  • Anxiety Disorders
  • Breast Neoplasms
  • Depression
  • Depressive Disorder
  • Hot Flashes

Name

Location

MBCCOP - HawaiiHonolulu, Hawaii  96813
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Greater PhoenixPhoenix, Arizona  85006-2726
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
CCOP - Northern New JerseyHackensack, New Jersey  07601
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - Marshfield Medical Research and Education FoundationMarshfield, Wisconsin  54449
MBCCOP - Gulf CoastMobile, Alabama  36688
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
CCOP - NorthwestTacoma, Washington  98405-0986
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224