Status:
ACTIVE_NOT_RECRUITING
The Effect of Acupuncture on Cancer-Related Cognitive Difficulties
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT04837820
Start Date
April 6 2021
End Date
April 1 2026
Last Update
April 23 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge (Limited Protocol activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limited Protocol activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Commack, New York, United States, 11725