Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial
Data Collection
Breast Diseases+3
+ Breast Neoplasms
+ Neoplasms
Supportive Care Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.80 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location