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

Who is this study for? Patients with Breast Cancer
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: No
View:

• 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

Locations
United States
New York
Memorial Sloan Kettering Suffolk- Commack (Limited Protocol Activities)
Recruiting
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Recruiting
Harrison
Memorial Sloan Kettering Cancer Center
Recruiting
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Recruiting
Uniondale
Contact Information
Primary
Jun Mao, MD,MSCE
maoj@mskcc.org
646-888-0866
Backup
Kevin Liou, MD
646-888-0864
Time Frame
Start Date: April 6, 2021
Estimated Completion Date: April 2025
Participants
Target number of participants: 260
Treatments
Experimental: Acupuncture
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
Placebo Comparator: Sham Acupuncture (SA)
The intervention will consist of 10 acupuncture sessions over 10 weeks using the standardized, semi-fixed protocol.
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).
Authors
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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