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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Other: Acupuncture

• Registration Number: NCT05417451
• Lead Sponsor: University of Illinois at Chicago

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.

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 Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-05-26
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-14
• Status Verified: 2025-02
• Primary Completion: 2025-02-26
• Study Completion: 2025-02-26
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
PROMIS Pain Interference	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
PROMIS Fatigue	After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)	Scores range from 4-20; higher scores indicate that severe fatigue
PROMIS Sleep Disturbance	After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)	Scores range from 4-20; higher scores indicate that severe sleep disturbance

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Illinois at Chicago College of Nursing; 🇺🇸 Chicago, Illinois, United States