Acupuncture in Treating Hot Flashes in Women With Breast Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Breast Cancer; Hot Flashes

Treatments: Procedure: acupuncture therapy; Procedure: hot flashes attenuation; Procedure: management of therapy complications

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00081965

02-108

MSKCC-02108A

Details and patient eligibility

About

RATIONALE: Acupuncture may help relieve hot flashes in women with breast cancer. It is not yet known whether acupuncture is more effective than a placebo in treating hot flashes in women with breast cancer

PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in treating hot flashes in women with breast cancer.

Full description

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.

Enrollment: 80 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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