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Completed

NCT Number: NCT05417451

Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors

The objectives of this study to explore whether acupuncture can improve the psychoneurological symptom cluster (pain, fatigue, sleep disturbance) in survivors of breast cancer and explore biomarker changes after the acupuncture intervention. Acupuncture treatments will be provided to breast cancer survivors twice weekly for 5 weeks.

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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 2

Primary location

University of Illinois at Chicago College of Nursing

Chicago, Illinois, 60612, United States

About this study

The investigators will conduct the study with early stage breast cancer survivors who have completed their primary cancer treatment. They will all receive acupuncture. Treatments will be twice weekly for 5 weeks, for 30 minutes per treatment. At baseline and post-treatment, subjects will be collected blood and stool samples, complete symptom questionnaires that measure pain, fatigue, and sleep disturbance.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women with histologically confirmed stage 0, I, II, or III breast cancer
  • who have completed their primary cancer treatment (e.g., surgery, radiotherapy, chemotherapy) at least 3 months prior and within 5 years
  • are currently receiving adjuvant endocrine therapy
  • are able to read and speak English
  • with self-reported pain, fatigue, sleep disturbance in the last three months and their "worst" severity rating ≥ 3 (0-10 numeric rating scale) for at least two of the three symptoms

Exclusion criteria

  • have self-reported hospitalization for psychiatric illness within the past 2 years
  • have a bleeding disorder
  • physically or cognitively unable to complete the study procedures
  • pregnant women

Treatment and study plan

Acupuncture

Other

All participants will receive a semi-standardized acupuncture protocol (standardized points for pain, fatigue, depression, anxiety, sleep disturbance, with additional points for patient's particular pain location)

Primary outcomes

  1. PROMIS Pain Interference

    Time frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)

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

  2. PROMIS Fatigue

    Time frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)

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

  3. PROMIS Sleep Disturbance

    Time frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)

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

Secondary outcomes

  1. PROMIS Depression

    Time frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)

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

  2. PROMIS Anxiety

    Time frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)

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

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jun 14, 2022
Registry last updated
Jul 23, 2025

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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