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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>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. | Other: Acupuncture<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| PROMIS Fatigue | Scores range from 4-20; higher scores indicate that severe fatigue | After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PROMIS Depression | Scores range from 4-20; higher scores indicate that severe depression | After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) | 
| PROMIS Anxiety | Scores range from 4-20; higher scores indicate that severe anxiety | After 10th acupuncture treatment, at 6 weeks post-baseline (study completion) |