Clinical trial · Observational
Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer
Deep Inspiration Breath-hold Radiotherapy for Left-sided Breast Cancer in Reducing Early Cardiac Injury: a Phase II Prospective Study
NCT05200078CI-TRIAL-00056038unknownClinicalTrials.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)
Postoperative breast radiotherapy (RT) has been associated with increased risk of heart toxicity. However, there is a lack of knowledge for radiation-induced early cardiovascular injury, especially for hypofractionated RT. This study aims to prospectively detect and predict early clinical or subclinical cardiac events in women undergoing adjuvant RT for breast cancer.
Conditions
Conditions (2)
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 |
| Cardiac Event | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Deep inspiration breath-hold technique | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Radiotherapy at free-breathing
- description
- breast/chest wall+-RNI 43.5Gy/15f/3w（tumor bed 49.5Gy/15f/3w) delivered at free-breathing
- label
- Radiotherapy at deep inspiration breath-hold
- description
- breast/chest wall+-RNI 43.5Gy/15f/3w（tumor bed 49.5Gy/15f/3w) delivered at deep inspiration breath-hold
- interventionNames
- Device: Deep inspiration breath-hold technique
Primary outcomes (1)
- measure
- Incidence of clinical or subclinical cardiac injury
- timeFrame
- two years
- description
- predefined cardiac events
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Primary left-sided breast cancer post surgery * Planning for adjuvant breast/chest wall +-RNI Exclusion Criteria: * History of cardiovascular disease * Previous chest radiation * Bilateral breast cancers
References
Publications (0)
Data not yet available
No reference posted for this study.