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

NCT05417451 | Completed Phase 2 DMC

• 1 other identifier: 2021-0840
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• PROMIS Depression

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

• PROMIS Anxiety

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

Study Arms (1)

Acupuncture

EXPERIMENTAL

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

Interventions

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)

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago College of Nursing

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 14, 2022
• Study Start: November 1, 2021
• Primary Completion: February 26, 2025
• Study Completion: February 26, 2025
• Last Updated: July 23, 2025

Record last verified: 2025-07

Locations

US (1)