Acupuncture Therapy in Reducing Hot Flashes in Patients with Estrogen Receptor Positive Stage I-III Breast Cancer

Status: closed to accrual

This trial studies how well acupuncture therapy works in reducing hot flashes in patients with estrogen receptor positive stage I-III breast cancer. Hot flashes are a common side effect of breast cancer treatment and are felt as a sensation of sudden onset body warmth, flushing, and sweating. 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 the body’s natural healing system. Acupuncture may help to reduce the number and intensity of hot flashes in breast cancer patients who are being treated with medications such as tamoxifen and aromatase inhibitors.

Inclusion Criteria

History of histologically or cytologically proven stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor; Stage 0 or ductal breast carcinoma in situ (DCIS) is allowable
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
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

PRIMARY OBJECTIVE:

I. To test the impact of acupuncture therapy (acupuncture) (versus wait list control) on the frequency and severity of hot flashes, as measured through hot flash diaries, in hormone receptor-positive breast cancer patients undergoing adjuvant hormonal therapy.

SECONDARY OBJECTIVES:

I. To test the impact of acupuncture (versus wait list control) on quality of life (Functional Assessment of Cancer Therapy- General [FACT-G]), breast cancer symptoms (Functional Assessment of Cancer Therapy- Breast Cancer [FACT-B]), and menopausal symptoms (Functional Assessment of Cancer Therapy- Endocrine Subscale [FACT-ES]) in hormone receptor positive breast cancer patients undergoing adjuvant endocrine therapy.

II. To test the impact of acupuncture (versus wait list control) on sleep quality and duration (as measured by Pittsburgh Sleep Quality Index [PSQI] and actigraphy) and patients' perception of their sleep quality (as measured by the sleep diary and Insomnia Severity Index) in hormone receptor-positive breast cancer patients undergoing adjuvant hormonal therapy and symptom burden.

III. To explore the effects of a high dose (20 sessions) versus a low dose (10 sessions) of the same acupuncture protocol on the frequency and severity of hot flashes in hormone receptor-positive breast cancer patients undergoing adjuvant hormonal therapy.

IV. To evaluate the impact of acupuncture on expression of inflammatory biomarkers, such as NF-kappaB, STAT-1 and STAT-3, and associated cytokines IL-8, TNF-alpha and IL-6, and T-cells.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive acupuncture therapy over 60 minutes twice weekly for 10 weeks. Patients then receive standard of care for 10 weeks.

ARM II: Patients receive standard of care for 10 weeks. Patients then receive acupuncture therapy over 60 minutes once weekly for 10 weeks.

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Acupuncture Therapy in Reducing Hot Flashes in Patients with Estrogen Receptor Positive Stage I-III Breast Cancer

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