Who is eligible for clinical trial NCT04837820?

Participants must meet the protocol's inclusion criteria for Breast Cancer. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT04837820 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-04-17

The Effect of Acupuncture on Cancer-Related Cognitive Difficulties (NCT04837820)

Effect and Mechanism of Acupuncture for Cancer-related Cognitive Difficulties (ENHANCE)

🔵 Active, Not Recruiting Phase2 🩺 Clinical Procedure Protocol Sponsor: Memorial Sloan Kettering Cancer Center

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to test whether acupuncture can improve cognitive difficulties and insomnia in survivors of breast cancer. Researchers will compare the effects of real acupuncture with those of placebo acupuncture and wait-list acupuncture. This study will also look at insomnia's link to cognitive difficulties. All study participants (receiving real acupuncture, placebo acupuncture, or wait-list acupuncture) will complete study questionnaires and/or have cognitive testing at Weeks 0, 4, 10, 14 and 26. After the Week 26 visit, your participation in this study will end. If you are assigned to receive placebo acupuncture or wait-list acupuncture, you will have the option of receiving up to 10 real acupuncture treatments within the six months after the study finishes.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (15 items).

Location: Memorial Sloan Kettering Basking Ridge (Limited Protocol activities) — Basking Ridge, New Jersey

Age range: 18 Years

🧪 Interventions in This Study

Acupuncture (PROCEDURE)
Sham Acupuncture (PROCEDURE)
Wait-List Control (WLC) (OTHER)
Questionnaires (OTHER)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

English-proficient adult women with a history of stage 0, I, II, or III breast cancer
Free of oncologic disease by clinical examination or history
Moderate or greater CRCD as indicated by a score of "quite a bit" or "very much" on at least one of the two items that specifically assess concentration and memory on the EORTC QLQ-C30 (version 3.0)
Report that cognitive functions worsened since cancer diagnosis by replying "Yes" to all 3 questions
Do you think or feel that your memory or mental ability has gotten worse since your cancer diagnosis?
Do you think your mind isn't as sharp now as it was before your cancer diagnosis?
Do you feel like these problems have made it harder to function on your job or take care of things around the home?
Presence of insomnia symptoms as indicated by a score ≥8 on the ISI134
Willing to adhere to all study-related procedures, including randomization to one of the 3 possible choices: acupuncture, sham acupuncture, or wait-list control

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Metastatic breast cancer (stage IV)
Less than 1 month since completion of surgery, chemotherapy or radiation therapy
Greater than 10 years since most recent breast cancer diagnosis
Use of acupuncture for sleep or cognitive symptom management within the past 3 months
Diagnosis of Alzheimer's disease, vascular dementia, Parkinson disease, or other organic brain disorder
Score of \>10 indicative of overt dementia on the Blessed Orientation-Memory-Concentration (BOMC)135
Primary psychiatric disorder not in remission
As per medical record or self-report, history of stroke or head injury requiring visit to the emergency room or hospitalization, with confirmed structural lesion on neuroimaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation.
Pre-existing, uncorrectable visual or auditory impairment that would preclude ability to complete the assessments
Initiation or change in hormonal or targeted therapy within the past 4 weeks
Plans to initiate or change hormonal or targeted therapy in the coming 8 weeks

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (7 Sites)

Memorial Sloan Kettering Basking Ridge (Limited Protocol activities) — Basking Ridge, New Jersey
Memorial Sloan Kettering Monmouth (Limited Protocol activities) — Middletown, New Jersey
Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities) — Commack, New York
Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York
Memorial Sloan Kettering Cancer Center — New York, New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York

📞 Contact the Study Coordinator

Phone: (800) 525-2225

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗