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The Effect of Acupuncture on Cancer-Related Cognitive Difficulties

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ClinicalTrials.gov Identifier: NCT04837820
Recruitment Status : Recruiting
First Posted : April 8, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE April 6, 2021
First Posted Date  ICMJE April 8, 2021
Last Update Posted Date July 27, 2021
Actual Study Start Date  ICMJE April 6, 2021
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2021)
cognitive difficulties [ Time Frame: 26 weeks ]
measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) instrument. FACT-Cog is a 37-item questionnaire with 4 subscales: perceived cognitive difficulties, impact on quality of life, comments from others, and perceived cognitive abilities. The FACT-Cog perceived cognitive impairment subscale (Cronbach's α 0.94) will be the primary outcome for the study. A subscale score is calculated by summing the 18 items of the subscale. The subscale score ranges from 0 to 72.
Original Primary Outcome Measures  ICMJE
 (submitted: April 6, 2021)
cognitive difficulties [ Time Frame: 26 weeks ]
measured by the Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) instrument.
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 The Effect of Acupuncture on Cancer-Related Cognitive Difficulties
Official Title  ICMJE Effect and Mechanism of Acupuncture for Cancer-related Cognitive Difficulties (ENHANCE)
Brief Summary

The purpose of this study is to test whether acupuncture can improve cognitive difficulties and insomnia in survivors of breast cancer. Researchers will compare the effects of real acupuncture with those of placebo acupuncture and wait-list acupuncture. This study will also look at insomnia's link to cognitive difficulties.

All study participants (receiving real acupuncture, placebo acupuncture, or wait-list acupuncture) will complete study questionnaires and/or have cognitive testing at Weeks 0, 4, 10, 14 and 26. After the Week 26 visit, your participation in this study will end. If you are assigned to receive placebo acupuncture or wait-list acupuncture, you will have the option of receiving up to 10 real acupuncture treatments within the six months after the study finishes.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
3-arm, parallel, randomized controlled trial comparing acupuncture vs. sham acupuncture vs. wait-list control.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Procedure: Acupuncture
    Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.
  • Procedure: Sham Acupuncture
    Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.
  • Other: Wait-List Control (WLC)
    Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians.
  • Other: Questionnaires
    Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 4, 10, 14, and 26. Average time to complete the patient-reported outcomes (PROs) is 30 minutes, which has been judged to be acceptable with minimal missing data;. 20 minutes of these 30 minutes will be completed during the neurocognitive battery.
Study Arms  ICMJE
  • Experimental: Acupuncture
    The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
    Interventions:
    • Procedure: Acupuncture
    • Other: Questionnaires
  • Placebo Comparator: Sham Acupuncture (SA)
    The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
    Interventions:
    • Procedure: Sham Acupuncture
    • Other: Questionnaires
  • Experimental: Wait-List Control
    During the 26-week waiting period, the CRC will contact patients in the WLC group at the same frequency as the acupuncture groups with respect to data collection. Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians. WLC patients will be compensated with real acupuncture treatments after Week 26 (end of study).
    Interventions:
    • Other: Wait-List Control (WLC)
    • Other: Questionnaires
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 6, 2021)
260
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2025
Estimated Primary Completion Date April 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • English-proficient adult women with a history of stage 0, I, II, or III breast cancer
  • Free of oncologic disease by clinical examination or history
  • Moderate or greater CRCD as indicated by a score of "quite a bit" or "very much" on at least one of the two items that specifically assess concentration and memory on the EORTC QLQ-C30 (version 3.0)
  • Report that cognitive functions worsened since cancer diagnosis by replying "Yes" to all 3 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?
  • Presence of insomnia symptoms as indicated by a score ≥8 on the ISI134
  • Willing to adhere to all study-related procedures, including randomization to one of the 3 possible choices: acupuncture, sham acupuncture, or wait-list control

Exclusion Criteria:

  • Metastatic breast cancer (stage IV)
  • Less than 1 month since completion of surgery, chemotherapy or radiation therapy
  • Greater than 10 years since most recent breast cancer diagnosis
  • Use of acupuncture for sleep or 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 indicative of overt dementia on the Blessed Orientation-Memory-Concentration (BOMC)135
  • Primary psychiatric disorder not in remission
  • As per medical record or self-report, history of stroke or head injury requiring visit to the emergency room or hospitalization, with confirmed structural lesion on neuroimaging, persistent cognitive difficulties impacting work or daily life, or required cognitive rehabilitation.
  • Pre-existing, uncorrectable visual or auditory impairment that would preclude ability to complete the assessments
  • Initiation or change in hormonal or targeted therapy within the past 4 weeks
  • Plans to initiate or change hormonal or targeted therapy in the coming 8 weeks
  • Altered dose of somnogenic medication (e.g. hypnotics, sedatives, antidepressants) in past 8 weeks
  • Enrolled or plans to enroll on another MSK neurocognitive study
  • Unable to provide informed consent for himself/herself
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Breast Cancer
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jun Mao, MD,MSCE 646-888-0866 maoj@mskcc.org
Contact: Kevin Liou, MD 646-888-0864
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04837820
Other Study ID Numbers  ICMJE 20-124
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 July 2021

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