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Acupuncture for Hot Flashes in Breast Cancer

N/A
Waitlist Available
Led By Weidong Lu, PhD, MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
History of histologically or cytologically proven Stage I-III breast cancer with estrogen receptor positive with HER-2 positive or negative tumor
Must not have
Uncontrolled seizure disorder or history of seizure
Undergoing chemotherapy or planned surgery, chemotherapy, change doses and regimen of hormonal therapy during the study period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights

Summary

This trial is testing if acupuncture can help reduce hot flashes.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Acupuncture may cause minor side effects such as slight bleeding, bruising at needle sites, dizziness, or fainting. However, it's generally considered safe when performed by a trained practitioner.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I had Stage I-III breast cancer that was estrogen receptor and possibly HER2 positive.
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I've had daily hot flashes for over a month.
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I have finished all my initial cancer treatments and surgeries.
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I am either before or after menopause.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have seizures that are not controlled by medication.
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I am currently undergoing or planning to undergo treatment changes, including surgery or chemotherapy, during the study.
Select...
I have not had a heart attack or unstable heart condition in the last 6 months.
Select...
I currently have a serious infection that is not under control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Mean Weekly HFS Score Between Acupuncture and Usual Care Arms at the End of Week 10
Secondary study objectives
Changes in the Endocrine Symptom Subscale (ESS) in Functional Assessment of Cancer Therapy- Endocrine Symptoms (FACT-ES)
Changes in the Total and Subscores in Functional Assessment of Cancer Therapy- Breast Cancer

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811
2%
Serious unexpected
2%
Pain on needling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bi-Weekly Acupuncture
Wait List

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acupuncture
2011
Completed Phase 3
~1240

Find a Location

Who is running the clinical trial?

The Comprehensive and Integrative Medicine Institute of South KoreaOTHER
3 Previous Clinical Trials
140 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,100 Previous Clinical Trials
353,013 Total Patients Enrolled
144 Trials studying Breast Cancer
21,928 Patients Enrolled for Breast Cancer
Weidong Lu, PhD, MPHPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Acupuncture (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03783546 — N/A
Breast Cancer Research Study Groups: Immediate Acupuncture, Delayed acupuncture
Breast Cancer Clinical Trial 2023: Acupuncture Highlights & Side Effects. Trial Name: NCT03783546 — N/A
Acupuncture (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03783546 — N/A
~13 spots leftby Sep 2025
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