Clinical trial · Interventional
Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer
A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients
NCT00328783CI-TRIAL-00089082completedN/AResults postedClinicalTrials.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 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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Breathing Coordinator (ABC) | Device | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Active Breathing Coordinator
- description
- Patients breathe through the ABC device
- interventionNames
- Device: Active Breathing Coordinator (ABC)
- Radiation: Radiation Therapy
Primary outcomes (2)
- measure
- Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues
- timeFrame
- At time of radiation
- description
- To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing. The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.