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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in mean weekly HFS score between acupuncture and usual care arms at the end of week 10

Secondary outcome measures

Changes in plasma proinflammatory cytokines

Changes in the total and subscores in Functional Assessment of Cancer Therapy- Breast Cancer

Changes in the total and subscores in Functional Assessment of Cancer Therapy- Endocrine Subscale

+2 more

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811

Serious unexpected

Pain on needling

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

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

1,078 Previous Clinical Trials

340,792 Total Patients Enrolled

141 Trials studying Breast Cancer

22,537 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any additional participants being enrolled for this research endeavor?

"The information on clinicaltrials.gov suggests that recruitment for this trial has stopped, as the last update was on September 2nd 2022. Notwithstanding, there are still over 2600 other studies currently seeking participants to join their trials."

Answered by AI

Recent research and studies

BMC Complementary Medicine and TherapiesJournal

Developing and Implementing a Self-monitoring Toolkit for a Coordinated Multinational Randomized Acupuncture Trial

Baedorf Kassis, Sylvia, Weidong Lu, Sarah A. White, Im Hee Shin, Sung Hwan Park, Young Ju Jeong, Chang Yao, Jennifer Ligibel, and Barbara E. Bierer. 2022. “Developing and Implementing a Self-monitoring Toolkit for a Coordinated Multinational Randomized Acupuncture Trial”. BMC Complementary Medicine and Therapies. Springer Science and Business Media LLC. doi:10.1186/s12906-022-03648-4.

clinicaltrials.govStudy

Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial

Weidong Lu, MB, MPH, PhD 2019. "Acupuncture for Hot Flashes in Hormone Receptor-Positive Breast Cancer, a Randomized Controlled Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03783546.

All > Hot Flashes