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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 : April 12, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Acupuncture Procedure: Sham Acupuncture Other: Wait-List Control (WLC) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
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
Official Title: Effect and Mechanism of Acupuncture for Cancer-related Cognitive Difficulties (ENHANCE)
Actual Study Start Date : April 6, 2021
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Acupuncture
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
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.

Placebo Comparator: Sham Acupuncture (SA)
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
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.

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).
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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast Cancer
Accepts Healthy Volunteers:   No
Criteria

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
  • Unable to provide informed consent for himself/herself

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04837820


Contacts
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Contact: Jun Mao, MD,MSCE 646-888-0866 maoj@mskcc.org
Contact: Kevin Liou, MD 646-888-0864

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jun Mao, MD, MSCE    646-888-0866      
Contact: Kevin Liou, MD    646-888-0864      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Jun Mao, MD, MSCE Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04837820    
Other Study ID Numbers: 20-124
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 12, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Acupuncture
Cancer-Related Cognitive Difficulties
20-124