Acupuncture for the Treatment of Hot Flashes in Breast Cancer Patients: A Randomized Controlled Trial
Collecte de données
Maladies du sein+3
+ Néoplasmes du sein
+ Néoplasmes par site
Soins de support
Résumé
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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.80 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Soins de support
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site