Acupuncture Therapy in Reducing Hot Flashes in Patients with Estrogen Receptor Positive Stage I-III Breast Cancer
- 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
- 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
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.
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) 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.
Trial Phase Phase NA
Trial Type Supportive care
Dana-Farber Harvard Cancer Center
- Primary ID 18-371
- Secondary IDs NCI-2019-01733
- Clinicaltrials.gov ID NCT03783546