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Acupuncture for Breast Cancer

N/A

Recruiting

Research Sponsored by University of Illinois at Chicago

Eligibility Criteria Checklist

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

Must have

With self-reported pain, fatigue, sleep disturbance in the last three months and their 'worst' severity rating ≥ 3 (0-10 numeric rating scale) for at least two of the three symptoms

Women with histologically confirmed stage 0, I, II, or III breast cancer

Must not have

Physically or cognitively unable to complete the study procedures

Have self-reported hospitalization for psychiatric illness within the past 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after 10th acupuncture treatment, at 6 weeks post-baseline (study completion)

Awards & highlights

No Placebo-Only Group

Summary

This trial will study whether acupuncture is a feasible and acceptable treatment for breast cancer survivors, and will explore changes in biomarkers after the acupuncture intervention.

Who is the study for?

This trial is for English-speaking women who finished primary breast cancer treatment (stages 0-III) at least 3 months ago but within the last 5 years, are on adjuvant endocrine therapy, and suffer from pain, fatigue, or sleep issues with a severity of ≥3. Excluded are those with recent psychiatric hospitalization, bleeding disorders, pregnancy or inability to complete study procedures.

What is being tested?

The study tests if acupuncture can alleviate psychoneurological symptoms like pain, fatigue, and sleep disturbances in breast cancer survivors. Participants will receive acupuncture treatments twice weekly over five weeks while researchers track changes in biomarkers.

What are the potential side effects?

Acupuncture may cause minor side effects such as slight bleeding or bruising at needle sites, dizziness or fainting during treatment. Most people find it relatively safe with minimal discomfort.

Eligibility Criteria

Inclusion Criteria

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

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I have experienced significant pain, fatigue, or sleep problems in the last three months.

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I have been diagnosed with early to mid-stage breast cancer.

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I am currently on hormone therapy for cancer.

Exclusion Criteria

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

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I am unable to complete study tasks due to physical or mental reasons.

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I have been hospitalized for a mental health issue in the last 2 years.

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I have a condition that affects my blood's ability to clot.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after 10th acupuncture treatment, at 6 weeks post-baseline (study completion)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after 10th acupuncture treatment, at 6 weeks post-baseline (study completion)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after 10th acupuncture treatment, at 6 weeks post-baseline (study completion) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

PROMIS Fatigue

PROMIS Pain Interference

PROMIS Sleep Disturbance

Secondary study objectives

PROMIS Anxiety

PROMIS Depression

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

1Treatment groups

Experimental Treatment

Group I: AcupunctureExperimental Treatment1 Intervention

All subjects will receive active acupuncture. The acupuncture intervention will consist of 10 acupuncture sessions, twice weekly for 5 weeks. There will be at least 1 day in between session.

0 / 6Eligibility criteria met