N/A
Completed N=112
Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer
Source: ClinicalTrials.gov NCT00328783 ↗Enrolled (actual)
112
Serious AEs
—
Results posted
Apr 2014
Primary outcomePrimary: Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues — 3.0; 1.1; 6.0; 5.4 Gy
Summary
The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues |
3.0; 1.1; 6.0; 5.4 | — |
| PRIMARY Proportion of Patients With Reduction in Radiation |
0.94; 0.88; 0.56; 0.35 | — |
| SECONDARY Toxicity Evaluation |
— | — |
| SECONDARY Change in Organs at Risk (OAR) Dosimetric Paramaters |
2.7; .88; 6.4; .31 | — |
| SECONDARY Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device. |
59; 27; 34; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields
- Adequate pulmonary function
- Presence of 5 cc of the heart or liver with the simulation fields
- Karnofsky Performance Status (KPS) equal to or greater than 70
Exclusion Criteria
- Pregnant women
- Patients who have had previous ipsilateral breast or thoracic radiation therapy
Data sourced from ClinicalTrials.gov (NCT00328783). 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.