Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional basic science trial for Breast Cancer
Eligibility Criteria
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)
- are able to read and speak English
- with self-reported pain, fatigue, sleep disturbance, depression, and/or anxiety in the last three months and their "worst" severity rating ≥ 3 (0-10 numeric rating scale) for at least two of the five 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
Sites / Locations
- University of Illinois at Chicago College of NursingRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Acupuncture
Arm Description
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.
Outcomes
Primary Outcome Measures
PROMIS Pain Interference
Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more
PROMIS Fatigue
Scores range from 4-20; higher scores indicate that severe fatigue
PROMIS Sleep Disturbance
Scores range from 4-20; higher scores indicate that severe sleep disturbance
Secondary Outcome Measures
PROMIS Depression
Scores range from 4-20; higher scores indicate that severe depression
PROMIS Anxiety
Scores range from 4-20; higher scores indicate that severe anxiety
Full Information
NCT ID
NCT05417451
First Posted
May 26, 2022
Last Updated
September 13, 2023
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT05417451
Brief Title
Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
Official Title
Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
May 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
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)
Primary Outcome Measure Information:
Title
PROMIS Pain Interference
Description
Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more
Time Frame
After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Title
PROMIS Fatigue
Description
Scores range from 4-20; higher scores indicate that severe fatigue
Time Frame
After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Title
PROMIS Sleep Disturbance
Description
Scores range from 4-20; higher scores indicate that severe sleep disturbance
Time Frame
After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Secondary Outcome Measure Information:
Title
PROMIS Depression
Description
Scores range from 4-20; higher scores indicate that severe depression
Time Frame
After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
Title
PROMIS Anxiety
Description
Scores range from 4-20; higher scores indicate that severe anxiety
Time Frame
After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongjin Li, PhD
Phone
312-413-9845
Email
hongjin@uic.edu
Facility Information:
Facility Name
University of Illinois at Chicago College of Nursing
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongjin Li
Email
hongjin@uic.edu
12. IPD Sharing Statement
Learn more about this trial
Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
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