Effects, Metabolic Mechanisms and Predictors of Response to Acupuncture in Treating Psychoneurological Symptoms Among Breast Cancer Survivors
Sponsored by University of Illinois at Chicago
About this study
The purpose of this study is to examine the effect, mediators and predictors of treatment response of acupuncture in treating the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) among breast cancer survivors.
Aim 1: compared to sham acupuncture and UC, determine the effect of acupuncture on a) the psychoneurological cluster (primary outcome) and b) pain, fatigue, and sleep disturbance as individual symptoms (secondary outcomes). Aim 2: examine the role of methylsulfonylmethane as mediator in the mechanisms of acupuncture on the psychoneurological cluster and each individual symptom from week 0 to week 6 (primary endpoint) and to week 12 (secondary endpoint). Aim 3: identify multilevel predictors of treatment response in the acupuncture group, including a) biological (metabolomic signature, age); 2) clinical (previous treatment) and 3) psychosocial (treatment expectancy) characteristics.
Where this study is enrolling
- I'm interested
University of Illinois Chicago College of Nursing,
Chicago, Illinois
Who can participate
Inclusion criteria
- ✓≥ 18 years of age
- ✓With histologically confirmed Stage 0-III ER/PR-positive HER2-negative breast cancer
- ✓Currently receiving adjuvant endocrine therapy
- ✓Completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior to recruitment
- ✓Acupuncture-naïve
- ✓Have self- reported pain, fatigue, and sleep disturbance in the last month with an average severity rating ≥ 3 (0-10 numeric rating scale) for at least 2 of the 3 symptoms.
Exclusion criteria
- ✕Taking methylsulfonylmethane or glutathione supplements
- ✕Physically or cognitively unable to complete the study procedures
- ✕Pregnant
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Trial data sourced from ClinicalTrials.gov.