Clinical trial · Interventional
Multi-Omics Study of the Effect and Mechanisms of Acupuncture on Psychoneurological Symptoms Among Breast Cancer Survivors
NCT05417451CI-TRIAL-00092502completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Acupuncture
- 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.
- interventionNames
- Other: Acupuncture
Primary outcomes (3)
- measure
- PROMIS Pain Interference
- timeFrame
- After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
- description
- Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more
- measure
- PROMIS Fatigue
- timeFrame
- After 10th acupuncture treatment, at 6 weeks post-baseline (study completion)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLi H, Gao S, Schlaeger JM, Choi H, Xia Y, Sun J, Doorenbos AZ. Changes in Glutathione Metabolites and Reactive Oxygen Species from Baseline to Post-Treatment in Breast Cancer Survivors with Psychoneurological Symptoms Receiving Acupuncture. Integr Cancer Ther. 2026 Jan-Dec;25:15347354251411913. doi: 10.1177/15347354251411913. Epub 2026 Feb 13. PMID 41685420