Prospective Trial for heart dose reduction during radiotherapy in deep Inspiration breath-hold for left-sided breast cancer patients

Prospective Trial for heart dose reduction during radiotherapy in deep Inspiration breath-hold for left-sided breast cancer patients - SAVE-HEART

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00011213

Enrollment

400

Registered

2017-01-11

Start date

2016-10-05

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50 D05

Interventions

Group 1: Breast cancer patients with indication for adjuvant Radiation therapy are treated as Standard in DIBH. Regarding this study we assess initially the patients cardio risk and anamnesis and late

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Indikation for Radiotherapy of the breast/thoracic wall +/- lymphatic pathways after BCS (breast conserving surgery) or mastektomie in left-sided breast cancer patients

Exclusion criteria

Exclusion criteria: breath-hold of more than 20 seconds not possible informed consent not possible

Design outcomes

Primary

Measure	Time frame
Dosimetric Analysis (dose-volume-Histogramm) and evaluation of heart dose reduction due to DIBH (Deep Inspiration Breath Hold)	—

Secondary

Measure	Time frame
• assessment of cardiac risk factors and anamnesis for stratification (procam-score) • assessement of Long time cardiac toxicity (Standard follow-up time) • Radiation doses to organs at risk (heart, lung, LAD, contrabreast) (during planning process) • stratification of anatomical caracteristics influencing dose reduction due to DIBH • locally disease free survival • distant disease free survival • Overall survival	—

Measure

Time frame

• assessment of cardiac risk factors and anamnesis for stratification (procam-score) • assessement of Long time cardiac toxicity (Standard follow-up time) • Radiation doses to organs at risk (heart, lung, LAD, contrabreast) (during planning process) • stratification of anatomical caracteristics influencing dose reduction due to DIBH • locally disease free survival • distant disease free survival • Overall survival

—

Countries

Germany

Contacts

Public ContactCLaus Belka

Klinikum Großhadern Klinik für Strahlentherapie und Radioonkologie

claus.belka@med.uni-muenchen.de004989440074521

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026