Status:
ACTIVE_NOT_RECRUITING
Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
The Comprehensive and Integrative Medicine Institute of South Korea
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT03783546
Start Date
January 15 2019
End Date
December 1 2025
Last Update
May 4 2025
Active Locations (1)
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1
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215