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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Acupuncture

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago College of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; All subjects will receive active acupuncture. The acupuncture intervention will consist of 10 acupuncture sessions, twice weekly for 5 weeks. There will be at least 1 day in between session.	Other: Acupuncture; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Pain Interference	Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more	After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
PROMIS Fatigue	Scores range from 4-20; higher scores indicate that severe fatigue	After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
PROMIS Sleep Disturbance	Scores range from 4-20; higher scores indicate that severe sleep disturbance	After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS Depression	Scores range from 4-20; higher scores indicate that severe depression	After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
PROMIS Anxiety	Scores range from 4-20; higher scores indicate that severe anxiety	After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): February 26, 2025
• Study Completion (Actual): February 26, 2025

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2021-0840

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No