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NCT Number: NCT07695948

Effects, Metabolic Mechanisms and Predictors of Response to Acupuncture in Treating Psychoneurological Symptoms Among Breast Cancer Survivors

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

University of Illinois Chicago College of Nursing,

Chicago, Illinois, 60612, United States

Location contact

Hongjin Li

CONTACT

[email protected]

5739335413

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Behavioral

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.

Sham Acupuncture

Behavioral

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 outcomes

  1. The psychoneurological symptom cluster

    Time frame: 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 outcomes

  1. PROMIS Pain Interference

    Time frame: week 0, week 6, week 12, week 24

    Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more

  2. PROMIS fatigue

    Time frame: week 0, week 6, week 12, week 24

    Scores range from 4-20; higher scores indicate that severe fatigue

  3. PROMIS sleep disturbance

    Time frame: Scores range from 4-20; higher scores indicate that severe fatigue

    Scores range from 4-20; higher scores indicate that severe sleep disturbance

  4. Serum methylsulfonylmethane concentration

    Time frame: week 0, week 6, week 12

    Change in serum methylsulfonylmethane concentration.

  5. GSH/GSSG

    Time frame: week 0, week 6, week 12

    The ratio of glutathione and oxidized glutathione

Study contacts

Contact information is provided by the study sponsor or research team.

Hongjin Li, PhD, RN, FAAN

CONTACT

[email protected]

312-413-9845

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 10, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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