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

This research study is evaluating acupuncture, a medical therapy in which hair-thin,
stainless steel needles are shallowly inserted into specific points to help the body's
natural healing process, as a possible treatment to reduce hot flashes.

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