Acupuncture for Hot Flashes in Hormone-Receptor-Positive Breast Cancer
- Conditions
- Neoplasms
- Registration Number
- KCT0003618
- Lead Sponsor
- The Catholic University of Daegu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 40
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.Completed 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.Age = 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.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Functional Assessment of Cancer therapy-Endocrine Subscale (FACT-ES)
- Secondary Outcome Measures
Name Time Method Functional Assessment of Cancer therapy-Breast cancer (FACT-B);Pittsburgh sleep quality index (PSQI);European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 36 & Breast Cancer-specific module 23 (EORTC QLQ-C30 & EORTC QLQ-BR23);Daily Hot Flash Diary (DHFD)