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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05417451
Other study ID # 2021-0840
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 1, 2021
Est. completion date May 31, 2025

Study information

Verified date September 2023
Source University of Illinois at Chicago
Contact Hongjin Li, PhD
Phone 312-413-9845
Email hongjin@uic.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
United States University of Illinois at Chicago College of Nursing Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Illinois at Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary PROMIS Fatigue Scores range from 4-20; higher scores indicate that severe fatigue After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Primary 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 PROMIS Depression Scores range from 4-20; higher scores indicate that severe depression After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Secondary PROMIS Anxiety Scores range from 4-20; higher scores indicate that severe anxiety After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
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