International multicentric randomized controlled trial of acupuncture in the treatment of hot flashes in hormone-receptor-positive breast cancer

Jiangsu Hospital of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•1. History of histologically or cytologically proven Stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor;
•2. Premenopausal or postmenopausal status;
•3. Post chemotherapy (if administered) and surgery;
•4. Currently undergoing adjuvant hormonal therapy (eg. Tamoxifen and/or Aromatase inhibitors) with or without ovarian function suppression for at least 4 weeks at the study entry;
•5. Reported persistent hot flashes for at least 4 weeks AND more than 14 episodes of hot flashes per week (2 hot flashes per day) during the week prior to the study entry;
•6. Aged >= 18 years;
•7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
•8. Signed informed consent.

•1. Currently undergoing chemotherapy or radiation or have surgery planned during protocol period;
•2. Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
•3. Uncontrolled seizure disorder or history of seizure;
•4. Active clinically significant uncontrolled infection;
•5. Use of acupuncture for hot flashes within 6 months prior to the study entry;
•6. Uncontrolled major psychiatric disorders, such as major depression or psychosis;
•7. Newly starting pharmacologic treatment of hot flashes such as selective serotonin reuptake inhibitors (SSRIs) and/or anti-convulsant for less than 4 weeks prior to study entry.

发起方

Jiangsu Hospital of Traditional Chinese Medicine