Acupuncture Pilot Study for Cancer-related Cognitive Function
Cancer-related Cognitive Function Acupuncture Pilot Study (CLARITY
1 other identifier
interventional
48
1 country
6
Brief Summary
This study is being done to explore whether acupuncture can improve cognitive difficulties in patients diagnosed with cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2019
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
July 2, 2019
CompletedFirst Posted
Study publicly available on registry
July 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
May 20, 2025
May 1, 2025
7 years
July 2, 2019
May 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognitive difficulties as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog)
The perceived cognitive difficulties subscale score of the Functional Assessment of Cancer / FACT-Cog will be the primary outcome for the study.
16 weeks
Study Arms (3)
Acupuncture
EXPERIMENTALSham Acupuncture (SA)
SHAM COMPARATORWait-List Control
OTHERThis arm is Closed to accrual.
Interventions
10 treatments of acupuncture over the course of 10 weeks with a +/- 7 day window
10 treatments of sham acupuncture over the course of 10 weeks with a +/- 7 day window. After the 16-week study concludes patients in this group will have the option of receiving up to 10 sessions of real acupuncture; however, these sessions must be completed within 6 months of study conclusion.
Optional real acupuncture after 16 weeks waiting period. This arm is Closed to accrual.
Eligibility Criteria
You may qualify if:
- English-speaking
- Age 18 ≥ years old
- Diagnosis (breast, colorectal, prostate or gynecological cancer)
- Completed initial cancer treatment (surgery, chemotherapy, and/or radiation therapy) at least one month prior to study enrollment (patients receiving maintenance cancer treatment with hormonal or targeted therapies are permitted)
- Must report moderate or greater perceived CD as indicated by a score of "quite a bit" or "very much" on at least one of the two items that specifically assess concentration (item #20) and memory (item #25) on the EORTC QLQ-C30 instrument (version 3.0)
- Must indicate that their cognitive functions have worsened since their cancer diagnosis by replying "Yes" to all of the following 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?
- Must be willing to adhere to all study-related procedures, including randomization to one of the 2 possible choices: acupuncture or sham acupuncture
You may not qualify if:
- Active disease
- Use of acupuncture for 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 on the Blessed Orientation-Memory-Concentration (BOMC) screening instrument
- Primary psychiatric disorder not in remission
- Initiation or change in medication (e.g., hypnotics, sedatives, and/or antidepressants) in the past 8 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Mao, MD, MSCE
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2019
First Posted
July 5, 2019
Study Start
July 1, 2019
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
May 20, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
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.