Clinical trial NCT04007770: Acupuncture Pilot Study for Cancer-related Cognitive Function
Official title: Cancer-related Cognitive Function Acupuncture Pilot Study (CLARITY
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Stage I Colorectal Cancer
Stage II Colorectal Cancer
Stage III Colorectal Cancer
Gynecologic Cancer
Stage I Gynecologic Cancer
Stage II Gynecologic Cancer
Stage III Gynecologic Cancer
Stage I Prostate Cancer
Stage II Prostate Cancer
Stage III Prostate Cancer
Keywords: Breast Cancer
Colorectal Cancer
Gynecologic Cancer
Acupuncture
Memorial Sloan Kettering Cancer Center
19-179
Prostate Cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Cognitive difficulties as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog)
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jun Mao, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: