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Breast CancerPhase 2NCT04837820

The Effect of Acupuncture on Cancer-Related Cognitive Difficulties

A Phase 2 study testing Acupuncture and Questionnaires in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Acupuncture and Questionnaires
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
270 participants
Where
7 sitesUnited States
Study dates
6 Apr 2021to Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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?
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  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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
  • Altered dose of somnogenic medication (e.g. hypnotics, sedatives, antidepressants) in past 8 weeks
  • Enrolled or plans to enroll on another MSK neurocognitive study
  • Unable to provide informed consent for himself/herself

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Memorial Sloan Kettering Basking Ridge (Limited Protocol activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (Limited Protocol Activities)

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth (Limited Protocol activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (Limited Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering Nassau (Limited Protocol Activities)

    Uniondale, New York, 11553

Other trials in United States

About this study

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

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.

Conditions
Breast Cancer
Being tested
Acupuncture, Sham Acupuncture, Wait-List Control (WLC), Questionnaires
Keywords
Acupuncture, Cancer-Related Cognitive Difficulties, 20-124
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AcupunctureProcedure or surgery

    Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.

  • Sham AcupunctureProcedure or surgery

    Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.

  • Wait-List Control (WLC)Other

    Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians.

  • QuestionnairesOther

    Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 0, 10, and 26. Average time to complete the surveys is 30 minutes, which has been judged to be acceptable with minimal missing data; 20 minutes of these 30 minutes will be completed during the neurocognitive battery. Patients will complete PROs online using Research Electronic Data Capture (REDCap) or over the phone with the CRC. Biospecimens will be collected in person at assessment visits. The neurocognitive battery will be administered remotely.

Study groups in NCT04837820
Study groupRoleWhat they receive
AcupunctureExperimentalThe intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
Receives: Procedure: Acupuncture; Other: Questionnaires
Sham Acupuncture (SA)Placebo comparatorThe intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
Receives: Procedure: Sham Acupuncture; Other: Questionnaires
Wait-List ControlExperimentalDuring 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).
Receives: Other: Wait-List Control (WLC); Other: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. cognitive difficulties

    measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) instrument. FACT-Cog is a 37-item questionnaire with 4 subscales: perceived cognitive difficulties, impact on quality of life, comments from others, and perceived cognitive abilities. The FACT-Cog perceived cognitive impairment subscale (Cronbach's α 0.94) will be the primary outcome for the study. A subscale score is calculated by summing the 18 items of the subscale. The subscale score ranges from 0 to 72.

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start6 Apr 2021
  3. Primary completionApr 2027 (estimated)
  4. Study completionApr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Parallel groups
Model description
3-arm, parallel, randomized controlled trial comparing acupuncture vs. sham acupuncture vs. wait-list control.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04837820
Sponsor's protocol ID
20-124
Status last verified
Apr 2026
First submitted
6 Apr 2021
Last updated
22 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Publications

  • Lampson K, Li X, Jyung H, Yang A, Garland SN, Root JC, Ahles TA, Mao JJ. Association Between Sleep Continuity and Cognition in Breast Cancer Survivors: A Cross-Sectional Study. JNCI Cancer Spectr. 2026 Sep 22:pkag094. doi: 10.1093/jncics/pkag094. Online ahead of print.

    PubMed 42770868

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acupuncture and Questionnaires in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cognitive difficulties (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04837820, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

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