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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

No Placebo-Only Group

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.

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I have not had a heart attack or unstable heart condition in the last 6 months.

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I currently have a serious infection that is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 weeks

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

Serious unexpected

Pain on needling

100%

80%

60%

40%

20%

Study treatment Arm

Bi-Weekly Acupuncture

Wait List

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 10Eligibility criteria met