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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
84
Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on your skin, with the goal of affecting body's natural healing system
the current standard of care with non-hormonal pharmacotherapy of western medicine
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10
Daily Hot Flash Diary (DHFD) The DHFD is a measure of self-reported hot flash data that uses a diary to record the frequency and severity of hot flashes based on a 4-point scale (i.e., mild, moderate, severe, or very severe) to provide a hot flash score/index that reflects both number and severity of hot flashes (i.e., sum of the number of hot flashes multiplied by a weighted severity). Patients were asked to record daily for a week at five time points through the trial: baseline, week 5, week 10, week 15, and week 20. Negative changes would suggest improvements in number, type, or severity.
Time frame: 10 weeks
Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer
Changes in scores were calculated as (Week-10 - baseline). Since a higher score on any FACT-B subscale indicates better quality of life, a positive change would suggest that the patient's score improved during that time interval.
Time frame: 10 weeks
Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES)
The ESS is one subscale of the FACT-ES that assesses hormonal symptoms of endocrine therapy. The score ranges from 0-76 with higher scores indicating greater freedom from symptoms. Changes in scores were calculated as (Week-10 - baseline). Since a higher score reflects increased freedom from hormonal symptoms, a positive change would suggest that the patient's symptoms improved during that time interval.
Time frame: 10 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.