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NCT Number: NCT04837820

The Effect of Acupuncture on Cancer-Related Cognitive Difficulties

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol activities), Basking Ridge, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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
  • 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

Treatment and study plan

Acupuncture

Procedure

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 acupuncture

Procedure

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.

questionnaires

Other

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.

Primary outcomes

  1. cognitive difficulties

    Time frame: 26 weeks

    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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2021
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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