Breast Cancer
Conditions
Brief summary
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
BEHAVIORALAcupuncture
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.
BEHAVIORALSham 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.
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The psychoneurological symptom cluster | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS Pain Interference | week 0, week 6, week 12, week 24 | Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more |
| PROMIS fatigue | week 0, week 6, week 12, week 24 | Scores range from 4-20; higher scores indicate that severe fatigue |
| PROMIS sleep disturbance | Scores range from 4-20; higher scores indicate that severe fatigue | Scores range from 4-20; higher scores indicate that severe sleep disturbance |
| Serum methylsulfonylmethane concentration | week 0, week 6, week 12 | Change in serum methylsulfonylmethane concentration. |
| GSH/GSSG | week 0, week 6, week 12 | The ratio of glutathione and oxidized glutathione |
Countries
United States
Contacts
CONTACTHongjin Li, PhD, RN, FAAN
Outcome results
None listed