A Phase 2 interventional study of Acupuncture and Sham Acupuncture in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 7 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 270 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Report that cognitive functions worsened since cancer diagnosis by replying "Yes" to all 3 questions
Exclusion Criteria:
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
Procedure: Acupuncture · Other: Questionnaires
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
Procedure: Sham Acupuncture · Other: Questionnaires
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).
Other: Wait-List Control (WLC) · Other: Questionnaires
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.
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.
Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians.
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.
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.
Time frame: 26 weeks
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Memorial Sloan Kettering Cancer Center