Acupuncture Pilot Study for Cancer-related Cognitive Function

Phase 2

Active, not recruiting

• Conditions: Stage I Colorectal Cancer; Stage III Colorectal Cancer; Stage I Gynecologic Cancer; Stage I Breast Cancer; Stage III Breast Cancer; Stage II Gynecologic Cancer; Stage III Gynecologic Cancer; Stage I Prostate Cancer; Stage III Prostate Cancer; Stage II Prostate Cancer
• Interventions: Other: Acupuncture; Other: Sham Acupuncture; Other: 16 week waiting period + optional Acupuncture

• Registration Number: NCT04007770
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-07-02
• Study First Submitted QC: 2019-07-02
• Study First Posted: 2019-07-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-17
• Last Update Posted: 2024-05-20
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture	Acupuncture	-
Sham Acupuncture (SA)	Sham Acupuncture	-
Wait-List Control	16 week waiting period + optional Acupuncture	This arm is Closed to accrual.

Primary Outcome Measures

Name	Time	Method
Cognitive difficulties as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog)	16 weeks	The perceived cognitive difficulties subscale score of the Functional Assessment of Cancer / FACT-Cog will be the primary outcome for the study.

Trial Locations

Locations (6)

Memorial Sloan Kettering Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen; 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau; 🇺🇸 Uniondale, New York, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States