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

Hot flashes are a sensation of sudden onset of body warmth, flushing and sweating. Hot
flashes are common side effects of breast cancer treatments and can affect mood and daily
life. Medications can help ease hot flashes, but many patients continue to experience
symptoms despite these treatments.

Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are
inserted into various spots on the skin, with the goal of affecting body's natural healing
system. Acupuncture has been tested in clinical trials in cancer patients and has been shown
to be helpful in treating a number of side effects of cancer treatment, such as nausea and
vomiting from chemotherapy. A few early studies have suggested that acupuncture may help to
lessen hot flashes, but more information is needed about the benefits of acupuncture in
breast cancer patients.

This study is being done to test whether acupuncture can help to reduce the number and
intensity of hot flashes in breast cancer patients who are being treated with mediations such
as tamoxifen and aromatase inhibitors, such as anastrozole (Arimidex), exemestane (Aromasin),
and letrozole (Femara).

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