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Acupuncture for Breast Cancer-Related Cognitive Difficulties

Phase 2

Recruiting

Led By Jun Mao, MD, MSCE

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Free of oncologic disease by clinical examination or history

Presence of insomnia symptoms as indicated by a score ≥8 on the ISI134

Must not have

Less than 1 month since completion of surgery, chemotherapy or radiation therapy

Pre-existing, uncorrectable visual or auditory impairment that would preclude ability to complete the assessments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 26 weeks

Summary

This trial is testing whether acupuncture can help breast cancer survivors with cognitive difficulties and insomnia. Patients will be randomly assigned to real acupuncture, placebo acupuncture, or wait-list acupuncture. There will be cognitive testing and questionnaires at different intervals to assess the effects of acupuncture.

Who is the study for?

This trial is for English-speaking adult women who've had stage 0-III breast cancer, are currently free of cancer, and have noticed a decline in memory or mental ability since their diagnosis. They should be experiencing insomnia and cognitive difficulties but not taking certain medications or undergoing other treatments that could affect the study's outcome.

What is being tested?

The study tests if acupuncture can help with cognitive issues and sleep problems after breast cancer treatment. It compares real acupuncture to placebo (fake) acupuncture and no treatment at all. Participants will answer questionnaires and undergo cognitive testing over several weeks to measure changes.

What are the potential side effects?

Acupuncture may cause minor side effects like bruising, bleeding 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 currently have no signs of cancer based on exams or my medical history.

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I have insomnia with a score of 8 or higher on the ISI.

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I am an English-speaking woman who has had stage 0 to III breast cancer.

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I often or very often have trouble with my memory or concentration.

Exclusion Criteria

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

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I finished my surgery, chemotherapy, or radiation less than a month ago.

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I do not have any severe vision or hearing problems that would stop me from completing health assessments.

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My breast cancer has spread to other parts of my body.

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I am unable to understand and give consent for treatment on my own.

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I have been diagnosed with a brain disorder such as Alzheimer's or Parkinson's.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 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

cognitive difficulties

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Wait-List ControlExperimental Treatment2 Interventions

During the 26-week waiting period, the CRC will contact patients in the WLC group at the same frequency as the acupuncture groups with respect to data collection. Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians. WLC patients will be compensated with real acupuncture treatments after Week 26 (end of study).

Group II: AcupunctureExperimental Treatment2 Interventions

The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.

Group III: Sham Acupuncture (SA)Placebo Group2 Interventions

The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acupuncture

2011

Completed Phase 3

~1240