Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- PROMIS Pain Interference
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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: Acupuncture (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- PROMIS Depression(After 10th acupuncture treatment, at 6 weeks post-baseline (study completion))
- PROMIS Anxiety(After 10th acupuncture treatment, at 6 weeks post-baseline (study completion))
Investigators
Hongjin Li
Assistant Professor
University of Illinois at Chicago