The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05417451
Recruitment Status : Recruiting
First Posted : June 14, 2022
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
Hongjin Li, University of Illinois at Chicago

Tracking Information
First Submitted Date  ICMJE May 26, 2022
First Posted Date  ICMJE June 14, 2022
Last Update Posted Date September 15, 2023
Actual Study Start Date  ICMJE November 1, 2021
Estimated Primary Completion Date May 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2023)
  • PROMIS Pain Interference [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) ]
    Scores range from 4-20; higher scores indicate that severe sleep disturbance
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2022)		 Feasibility and Acceptability for Treating Psychoneurological Symptoms With Acupuncture [ Time Frame: Time Frame: After 10th acupuncture treatment, at 5 weeks post-baseline (study completion) ]
Protocol Acceptability Scale is a 10-item instrument with scores ranging from 0 to 20 used to measure acceptability of the study processes and protocols. Items are measured on a 0 to 2 scale, where 0 means "did not like the study/did not like acupuncture/did not enjoy participating", and 2 means "liked the study/liked acupuncture/enjoyed participating". The protocol was deemed to have high acceptability if 80% of participants scored ≥ 80% of possible points on the acceptability scale. The investigators calculated the mean score for each of the 10 questions, divided the total score for the 10 questions by the maximum possible points for the measure, and converted the total mean scores to percentage of participants who liked the study/liked acupuncture/enjoyed participating.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2023)
  • PROMIS Depression [ Time Frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) ]
    Scores range from 4-20; higher scores indicate that severe depression
  • PROMIS Anxiety [ Time Frame: After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) ]
    Scores range from 4-20; higher scores indicate that severe anxiety
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
Official Title  ICMJE Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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)
Study Arms  ICMJE Experimental: 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.
Intervention: Other: Acupuncture
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2023)		 66
Original Actual Enrollment  ICMJE
 (submitted: June 8, 2022)		 8
Estimated Study Completion Date  ICMJE May 31, 2025
Estimated Primary Completion Date May 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hongjin Li, PhD 312-413-9845 hongjin@uic.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05417451
Other Study ID Numbers  ICMJE 2021-0840
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hongjin Li, University of Illinois at Chicago
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Illinois at Chicago
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Illinois at Chicago
Verification Date September 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP