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出境医 / 临床实验 / Acupuncture Pilot Study for Cancer-related Cognitive Function

Acupuncture Pilot Study for Cancer-related Cognitive Function

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

Condition or disease Intervention/treatment Phase
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 Other: Acupuncture Other: Sham Acupuncture Other: 16 week waiting period + optional Acupuncture Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Cancer-related Cognitive Function Acupuncture Pilot Study (CLARITY
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Acupuncture Other: Acupuncture
10 treatments of acupuncture over the course of 10 weeks with a +/- 7 day window
Sham Comparator: Sham Acupuncture (SA) Other: 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.
Wait-List Control
This arm is Closed to accrual.
 Other: 16 week waiting period + optional Acupuncture
Optional real acupuncture after 16 weeks waiting period. This arm is Closed to accrual.
Outcome Measures
Primary Outcome Measures :
  1. Cognitive difficulties as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) [ Time Frame: 16 weeks ]
    The perceived cognitive difficulties subscale score of the Functional Assessment of Cancer / FACT-Cog will be the primary outcome for the study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Memoral Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
United States, New York
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Jun Mao, MD, MSCE Memorial Sloan Kettering Cancer Center
Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date June 7, 2021
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2019) 		Cognitive difficulties as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) [ Time Frame: 16 weeks ]
The perceived cognitive difficulties subscale score of the Functional Assessment of Cancer / FACT-Cog will be the primary outcome for the study.
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019) 		Cognitive difficulties as measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) [ Time Frame: 16 weeks ]
The perceived cognitive difficulties subscale scare of the FACT-Cog will be the primary outcome for the study.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture Pilot Study for Cancer-related Cognitive Function
Official Title  ICMJE Cancer-related Cognitive Function Acupuncture Pilot Study (CLARITY
Brief Summary This study is being done to explore whether acupuncture can improve cognitive difficulties in patients diagnosed with cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Other: Acupuncture
    10 treatments of acupuncture over the course of 10 weeks with a +/- 7 day window
  • Other: 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.
  • Other: 16 week waiting period + optional Acupuncture
    Optional real acupuncture after 16 weeks waiting period. This arm is Closed to accrual.
Study Arms  ICMJE
  • Experimental: Acupuncture
    Intervention: Other: Acupuncture
  • Sham Comparator: Sham Acupuncture (SA)
    Intervention: Other: Sham Acupuncture
  • Wait-List Control
    This arm is Closed to accrual.
    Intervention: Other: 16 week waiting period + optional Acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 12, 2021) 		48
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2019) 		80
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007770
Other Study ID Numbers  ICMJE 19-179
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jun Mao, MD, MSCE Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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