Effects, Metabolic Mechanisms and Predictors of Response to Acupuncture in Treating Psychoneurological Symptoms Among Breast Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture, Sham acupuncture.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Behavioral Acupuncture
All participants will receive a semi-standardized acupuncture protocol with needle penetrating to the skin. Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes. - Behavioral Sham acupuncture
Participants will receive no-touch control needle on non- acupuncture points, with the tip that does not contact the skin. Participants will receive 2 sham acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each sham acupuncture treatment will take 30 minutes.
Primary outcome measures
- The psychoneurological symptom cluster [Time frame: week 0, week 6, week 12, week 24]
Secondary outcome measures (5)
- PROMIS Pain Interference [Time frame: week 0, week 6, week 12, week 24]
- PROMIS fatigue [Time frame: week 0, week 6, week 12, week 24]
- PROMIS sleep disturbance [Time frame: Scores range from 4-20; higher scores indicate that severe fatigue]
- Serum methylsulfonylmethane concentration [Time frame: week 0, week 6, week 12]
- GSH/GSSG [Time frame: week 0, week 6, week 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Illinois Chicago College of Nursing, — Chicago
Identifiers
NCT: NCT07695948 · 2026-0010