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Behavioural Intervention

Acutherapy for Joint Pain in Breast Cancer

N/A

Waitlist Available

Led By Demetria Smith-Graziani, MD,MPH

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-identified Non-Hispanic Black woman

Planned to start adjuvant AI

Must not have

Diagnosed with metastatic breast cancer

Premenopausal status

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months after ai start

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if in-person acupuncture or virtual acupressure can help prevent joint pain caused by aromatase inhibitors in Non-Hispanic Black postmenopausal women with early-stage

Who is the study for?

This trial is for Non-Hispanic Black postmenopausal women with stage I-III hormone receptor positive breast cancer who are taking aromatase inhibitors. It aims to help those suffering from joint pain due to their medication. Participants should not have started AI therapy more than a month ago and must be able to attend in-person or virtual sessions.

What is being tested?

The study tests if acupuncture (inserting thin needles into the skin) or acupressure (applying pressure on specific body points) can prevent joint pain caused by aromatase inhibitor therapy in participants. The effectiveness of these complementary therapies will be compared through surveys and discussions.

What are the potential side effects?

Potential side effects from acupuncture may include slight bleeding, bruising, or soreness at needle sites. Acupressure might cause temporary discomfort or tenderness at pressure points. Both methods aim to reduce pain rather than cause it.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a Non-Hispanic Black woman.

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I am scheduled to start hormone therapy after surgery.

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I am 18 years old or older.

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I have early to mid-stage breast cancer that is hormone receptor positive and HER2 negative.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with breast cancer that has spread.

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I have not gone through menopause.

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I have been diagnosed with rheumatoid arthritis, multiple sclerosis, or muscular dystrophy.

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I have used or am using CDK 4/6 inhibitors.

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I have been treated with hormone therapy before surgery for cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 6 months after starting study intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 6 months after starting study intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months after starting study intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brief pain inventory (BPI) pain severity score

Incidence of arthralgias

Secondary study objectives

AI adherence

Intervention completion rate

Pain severity

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (acupressure, AI therapy)Experimental Treatment4 Interventions

Patients undergo self-administered acupressure therapy virtually over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive SOC AI therapy.

Group II: Arm I (acupuncture, AI therapy)Experimental Treatment4 Interventions

Patients undergo acupuncture therapy in-person over 1 hour twice weekly for the first 6 weeks and then once weekly for 6 weeks and receive standard of care (SOC) aromatase inhibitor (AI) therapy.

Group III: Arm III (AI therapy)Active Control2 Interventions

Patients receive SOC AI therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aromatase Inhibition Therapy

2011

Completed Phase 3

~3500

Acupressure Therapy

2021