Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial


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Not Enrolling
Female
Breast Cancer, Hot Flashes

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Trial Information

Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial


OBJECTIVES:

Primary

- Determine whether acupuncture, compared to placebo, reduces the incidence of hot
flashes in women with breast cancer.

Secondary

- Determine the long-term effects of acupuncture on hot flashes.

OUTLINE: This a randomized, placebo-controlled, multicenter study. Patients are stratified
according to concurrent treatment with selective estrogen receptor modulators,
gonadotropin-releasing hormone analogs, or aromatase inhibitors (yes vs no), concurrent use
of hot flash medication or selective serotonin reuptake inhibitors (SSRIs) (yes vs no),
baseline hot flash frequency (> 7 per day), and menopausal status at diagnosis
(premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.

- Arm I (treatment): Patients receive 8 acupuncture treatments over 4 weeks.

- Arm II (control): Patients receive 8 placebo acupuncture treatments over 4 weeks.
Beginning at week 7, patients are offered 8 true acupuncture treatments over 4 weeks.

Patients in both arms complete a "hot flash" diary for 1 week before treatment and then
periodically during and after treatment.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of breast cancer (including in situ disease)

- Must be receiving treatment for breast cancer at Memorial Sloan Kettering Cancer
Center (MSKCC) or its regional site (Commack)

- Has an average of 3 or more hot flashes a day during 1 week of baseline diary
recording

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Female

- Pre- or postmenopausal

- Karnofsky performance status 70-100%

- Ambulatory

- No skin infection

PRIOR CONCURRENT THERAPY:

- More than 3 weeks since prior and no concurrent treatment with any of the following
during the 6 week evaluation period of the trial:

- Surgery

- Initiation of a new chemotherapy regimen

- Initiation of immunotherapy

- Initiation of radiotherapy

- Initiation or cessation of hormonal therapy

- More than 6 weeks since prior acupuncture treatment (6 months for acupuncture
specifically for the treatment of hot flashes)

- No concurrent pharmacological treatment for hot flashes unless dose has been stable
for 4 weeks

- No concurrent selective serotonin reuptake inhibitors (SSRIs) unless dose has been
stable for 4 weeks

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Frequency and severity of hot flashes, as measured by a hot flash diary

Principal Investigator

Barrie R. Cassileth, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

02-108

NCT ID:

NCT00081965

Start Date:

Completion Date:

May 2007

Related Keywords:

  • Breast Cancer
  • Hot Flashes
  • breast cancer in situ
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • stage IIIC breast cancer
  • hot flashes
  • Breast Neoplasms
  • Hot Flashes

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021