N/A
Completed N=26
Ear Acupuncture During Chemotherapy Infusion for Breast Cancer, a Feasibility Study
Source: ClinicalTrials.gov NCT03170648 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: Feasibility of Patient Enrollment and Intervention Adherence — 100; 92.3; 84.6 percentage of participants
Summary
This research study is evaluating ear acupuncture as a possible treatment to reduce symptoms related to receiving chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Patient Enrollment and Intervention Adherence |
100; 92.3; 84.6 | — |
| SECONDARY Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Education Cycle (Cycle 2) |
-1.1; 1.4; 7.4 | — |
| SECONDARY Changes in Edmonton Symptom Assessment System Revised (ESAS-R) Score Relative to Baseline at Acupuncture Cycle (Cycle 3 and Cycle 4) |
17.3; -3.0; -2.3; -0.5 | — |
| SECONDARY Changes in State-Trait Anxiety Inventory (STAI) Score Relative to Baseline Between Education (Cycle 2) and Acupuncture (Cycle 3 and 4) |
37.9; 35.6; -1.5; -4.9; 0.0; -2.6 | 0.02 sig |
| SECONDARY Number of Participants Experienced Acupuncture-related Adverse Effects |
— | — |
Eligibility Criteria
Inclusion Criteria
- History of histologically or cytologically proven Stage I-III breast cancer receiving intravenous chemotherapy on an every 14 days or every 21 days schedule
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Signed informed consent
Exclusion Criteria
- Receiving weekly chemotherapy
- Unstable cardiac disease or myocardial infarction within 6 months prior to study entry
- Uncontrolled seizure disorder
- Pregnancy or potential pregnancy
- Active clinically significant uncontrolled infection
- Prior use of acupuncture within 3 months prior to the study entry
- Uncontrolled major psychiatric disorders, such as major depression or psychosis
- Metastatic breast or other cancer
Data sourced from ClinicalTrials.gov (NCT03170648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.