Acupuncture Pilot Study for Cancer-related Cognitive Function

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Phase 2

Conditions: Stage II Colorectal Cancer; Stage III Colorectal Cancer; Stage II Gynecologic Cancer; Stage I Colorectal Cancer; Stage I Breast Cancer; Stage I Prostate Cancer; Stage III Gynecologic Cancer; Stage III Prostate Cancer; Stage II Prostate Cancer; Stage I Gynecologic Cancer; Gynecologic Cancer; Stage II Breast Cancer; Stage III Breast Cancer

Treatments: Other: Sham Acupuncture; Other: 16 week waiting period + optional Acupuncture; Other: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT04007770

19-179

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 3 patient groups

Acupuncture

Experimental group

Treatment:

Other: Acupuncture

Sham Acupuncture (SA)

Sham Comparator group

Treatment:

Other: Sham Acupuncture

Wait-List Control

Other group

Description:

This arm is Closed to accrual.

Treatment:

Other: 16 week waiting period + optional Acupuncture