NCT04837820

The Effect of Acupuncture on Cancer-Related Cognitive Difficulties

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2021-04-06
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2021-04-08
• Last updated: 2025-04-23

Locations

7 sites across 1 country: United States