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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04007770
Other study ID # 19-179
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2019
Est. completion date July 2025

Study information

Verified date May 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 48
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Acupuncture
10 treatments of acupuncture over the course of 10 weeks with a +/- 7 day window
Sham Acupuncture
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
Optional real acupuncture after 16 weeks waiting period. This arm is Closed to accrual.

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey
United States Memorial Sloan Kettering Commack Commack New York
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
United States Memorial Sloan Kettering Bergen Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center New York New York
United States Memorial Sloan Kettering Nassau Uniondale New York

Sponsors (1)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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