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Acupuncture Pilot Study for Cancer-related Cognitive Function

Primary Purpose

Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sham Acupuncture
16 week waiting period + optional Acupuncture
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage I Breast Cancer focused on measuring Breast Cancer, Colorectal Cancer, Gynecologic Cancer, Acupuncture, Memorial Sloan Kettering Cancer Center, 19-179, Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge
  • Memorial Sloan Kettering Monmouth
  • Memorial Sloan Kettering Bergen
  • Memorial Sloan Kettering Commack
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Nassau

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

Other

Arm Label

Acupuncture

Sham Acupuncture (SA)

Wait-List Control

Arm Description

This arm is Closed to accrual.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2019
Last Updated
May 16, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04007770
Brief Title
Acupuncture Pilot Study for Cancer-related Cognitive Function
Official Title
Cancer-related Cognitive Function Acupuncture Pilot Study (CLARITY
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Title
Sham Acupuncture (SA)
Arm Type
Sham Comparator
Arm Title
Wait-List Control
Arm Type
Other
Arm Description
This arm is Closed to accrual.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
10 treatments of acupuncture over the course of 10 weeks with a +/- 7 day window
Intervention Type
Other
Intervention Name(s)
Sham Acupuncture
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
16 week waiting period + optional Acupuncture
Intervention Description
Optional real acupuncture after 16 weeks waiting period. This arm is Closed to accrual.
Primary Outcome Measure Information:
Title
Cognitive difficulties as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog)
Description
The perceived cognitive difficulties subscale score of the Functional Assessment of Cancer / FACT-Cog will be the primary outcome for the study.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Mao, MD, MSCE
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center

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Acupuncture Pilot Study for Cancer-related Cognitive Function

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