The Effect of Acupuncture on Cancer-Related Cognitive Difficulties

Breast Cancer Clinical Trial

Official title:

Effect and Mechanism of Acupuncture for Cancer-related Cognitive Difficulties (ENHANCE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04837820
• Other study ID #: 20-124
• Status: Recruiting
• Phase: Phase 2
• Start date: April 6, 2021
• Est. completion date: April 2025

Study information

• Verified date: February 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Jun Mao, MD,MSCE
• Phone: 646-888-0866
• Email: maoj[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.
• 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.
• Questionnaires
Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 0, 10, and 26. Average time to complete the surveys 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. Patients will complete PROs online using Research Electronic Data Capture (REDCap) or over the phone with the CRC. Biospecimens will be collected in person at assessment visits. The neurocognitive battery will be administered remotely.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (Limited Protocol activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (Limited Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (Limited Protocol activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (Limited Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering Nassau (Limited Protocol Activities)	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive difficulties	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 a 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.	26 weeks

External Links

•   Memorial Sloan Kettering Cancer Center