Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled T… (NCT03783546) | Clinical Trial Compass
CompletedNot Applicable
Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial
United States84 participantsStarted 2019-01-15
Plain-language summary
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.
Who can participate
Age range18 Years
SexFEMALE
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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 …
What they're measuring
1
Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10