Effects, Metabolic Mechanisms and Predictors of Response to Acupuncture in Treating Psychoneurological Symptoms Among Breast Cancer Survivors
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- The psychoneurological symptom cluster
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •≥ 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.
排除标准
- •Taking methylsulfonylmethane or glutathione supplements
- •Physically or cognitively unable to complete the study procedures
研究组 & 干预措施
Acupuncture group
Participants will receive 2 acupuncture treatments each week for 5 weeks, for a total of 10 treatments. Each acupuncture treatment will take 30 minutes.
干预措施: Acupuncture (Behavioral)
Usual care group
Participants will continue to receive their usual care.
Sham acupuncture group
Sham acupuncture group will use a no-touch control needle on non-acupuncture points, with the tip not contacting 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.
干预措施: Sham acupuncture (Behavioral)
结局指标
主要结局
The psychoneurological symptom cluster
时间窗: week 0, week 6, week 12, week 24
Psychoneurological symptom cluster: The psychoneurological symptom cluster will be calculated as the mean of the Patient-Reported Outcomes Measurement Information System (PROMIS)-29 T-scores for Pain Interference, Fatigue, and Sleep Disturbance. Each domain is scored as a standardized T-score (approximate range 20-80), with higher scores indicating worse symptom severity. Higher composite scores indicate greater psychoneurological symptom burden.
次要结局
- PROMIS Pain Interference(week 0, week 6, week 12, week 24)
- PROMIS fatigue(week 0, week 6, week 12, week 24)
- PROMIS sleep disturbance(Scores range from 4-20; higher scores indicate that severe fatigue)
- Serum methylsulfonylmethane concentration(week 0, week 6, week 12)
- GSH/GSSG(week 0, week 6, week 12)
研究者
Hongjin Li
Associate Professor
University of Illinois at Chicago