Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer Read More

Inclusion Criteria:

• History of histologically or cytologically proven Stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor;
• Premenopausal or postmenopausal status;
• Completed all primary chemotherapy and surgery;
• Currently undergoing adjuvant hormonal therapy (e.g. Tamoxifen and/or Aromatase inhibitors) with or without ovarian function suppression for at least 4 weeks at study entry; the use of Trastuzumab after adjuvant chemotherapy is allowed;
• 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;
• Age ≥ 18 years;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Signed informed consent

Exclusion Criteria:

Undergoing chemotherapy or planned surgery, chemotherapy, change doses and regimen of hormonal therapy during the study period;

• Unstable cardiac disease or myocardial infarction within 6 months prior to study entry;
• Uncontrolled seizure disorder or history of seizure;
• Active clinically significant uncontrolled infection;
• Use of acupuncture for hot flashes within 6 months prior to the study entry;
• Uncontrolled major psychiatric disorders, such as major depression or psychosis;
• 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. Participants may continue with medications or therapies for the treatment of hot-flashes while participating in the study if the medication has been taking for more than 4 weeks prior to study entry AND the dose of the medication is going to be kept consistently during the study