NCT07695948

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
61mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2031

Last Updated

July 13, 2026

Status Verified

July 1, 2026

Enrollment Period

5 years

First QC Date

July 5, 2026

Last Update Submit

July 10, 2026

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • The psychoneurological symptom cluster

    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.

    week 0, week 6, week 12, week 24

Secondary Outcomes (5)

  • PROMIS Pain Interference

    week 0, week 6, week 12, week 24

  • PROMIS fatigue

    week 0, week 6, week 12, week 24

  • PROMIS sleep disturbance

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

  • Serum methylsulfonylmethane concentration

    week 0, week 6, week 12

  • GSH/GSSG

    week 0, week 6, week 12

Study Arms (3)

Acupuncture group

EXPERIMENTAL
Behavioral: Acupuncture

Sham acupuncture group

SHAM COMPARATOR
Behavioral: Sham acupuncture

Usual care group

NO INTERVENTION

Participants will continue to receive their usual care.

Interventions

AcupunctureBEHAVIORAL

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.

Acupuncture group
Sham acupunctureBEHAVIORAL

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.

Sham acupuncture group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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.

You may not qualify if:

  • Taking methylsulfonylmethane or glutathione supplements
  • Physically or cognitively unable to complete the study procedures
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Chicago College of Nursing,

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Central Study Contacts

Hongjin Li, PhD, RN, FAAN

CONTACT

312-413-9845hongjin@uic.edu

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 10, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2031

Study Completion (Estimated)

August 31, 2031

Last Updated

July 13, 2026

Record last verified: 2026-07

Locations

US(1)