Acupuncture Pilot Study for Cancer-related Cognitive Function

Gynecologic Cancer Clinical Trial

Official title:

Cancer-related Cognitive Function Acupuncture Pilot Study (CLARITY

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04007770
• Other study ID #: 19-179
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• 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 2024
• Est. primary completion date: July 2024
• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Colorectal Neoplasms
• Gynecologic Cancer
• Prostatic Neoplasms
• Stage I Breast Cancer
• Stage I Colorectal Cancer
• Stage I Gynecologic Cancer
• Stage I Prostate Cancer
• Stage II Breast Cancer
• Stage II Colorectal Cancer
• Stage II Gynecologic Cancer
• Stage II Prostate Cancer
• Stage III Breast Cancer
• Stage III Colorectal Cancer
• Stage III Gynecologic Cancer
• Stage III Prostate Cancer

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

External Links

•   Memorial Sloan Kettering Cancer Center