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OpenTrials
Active, Not Recruiting

NCT Number: NCT04007770

Acupuncture Pilot Study for Cancer-related Cognitive Function

This study is being done to explore whether acupuncture can improve cognitive difficulties in patients diagnosed with cancer.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Acupuncture

Other

10 treatments of acupuncture over the course of 10 weeks with a +/- 7 day window

Sham Acupuncture

Other

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.

16 week waiting period + optional Acupuncture

Other

Optional real acupuncture after 16 weeks waiting period. This arm is Closed to accrual.

Primary outcomes

  1. Cognitive difficulties as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog)

    Time frame: 16 weeks

    The perceived cognitive difficulties subscale score of the Functional Assessment of Cancer / FACT-Cog will be the primary outcome for the study.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Cancer-related Cognitive Function Acupuncture Pilot Study (CLARITY

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2019
Registry last updated
May 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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