Acupuncture for Hot Flashes in Breast Cancer
Recruiting in Palo Alto (17 mi)
Overseen byWeidong Lu, PhD, MPH
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Dana-Farber Cancer Institute
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for adults over 18 with Stage I-III hormone receptor-positive breast cancer who've finished primary treatment and are on hormonal therapy. They must have frequent hot flashes, be in good physical condition, and not planning further chemotherapy or surgery during the study.Inclusion Criteria
I am fully active or restricted in physically strenuous activity but can do light work.
I had Stage I-III breast cancer that was estrogen receptor and possibly HER2 positive.
I have been on hormone therapy for cancer, like Tamoxifen, for at least 4 weeks.
+5 more
Exclusion Criteria
I have seizures that are not controlled by medication.
I am currently undergoing or planning to undergo treatment changes, including surgery or chemotherapy, during the study.
I started medication for hot flashes less than 4 weeks ago or have been on a stable dose for more than 4 weeks.
+4 more
Participant Groups
The study tests acupuncture as a potential remedy for reducing hot flashes against usual care without acupuncture. Participants will be randomly assigned to receive either acupuncture or their regular treatment to compare outcomes.
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate AcupunctureExperimental Treatment1 Intervention
* Will receive a standardized acupuncture protocol for a 10-week period
* 20 sessions: twice a week for 10 weeks
* After the completion of the 10 weeks main study period, participants will cross over to the usual care as a follow-up without acupuncture for additional 10 weeks.
Group II: Delayed acupunctureActive Control1 Intervention
* Will receive standard usual care without acupuncture for 10 weeks
* Participants will cross over to receive the same acupuncture protocol for 10 weeks --10 sessions: once a week for 10 weeks before exiting the study
Acupuncture is already approved in United States, European Union, China, Australia for the following indications:
πΊπΈ Approved in United States as Acupuncture for:
- Pain management
- Hot flashes
- Fatigue
- Sleep disturbances
- Anxiety
- Depression
- Neuropathy
πͺπΊ Approved in European Union as Acupuncture for:
- Pain management
- Hot flashes
- Fatigue
- Sleep disturbances
- Anxiety
- Depression
π¨π³ Approved in China as Acupuncture for:
- Pain management
- Hot flashes
- Fatigue
- Sleep disturbances
- Anxiety
- Depression
- Neuropathy
π¦πΊ Approved in Australia as Acupuncture for:
- Pain management
- Hot flashes
- Fatigue
- Sleep disturbances
- Anxiety
- Depression
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dana Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
The Comprehensive and Integrative Medicine Institute of South KoreaCollaborator