Acute radiation-induced skin reactions following hypofractionated vs. conventional whole-breast radiotherapy in breast cancer patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017763

Enrollment

150

Registered

2019-07-30

Start date

2017-10-02

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

L58 C50

Interventions

Group 1: Hypofractionated whole-breast irradiation (40,05 Gy in 15 fractions) Group 2: Conventionally fractionated whole-breast irradiation (50 Gy in 25 fractions)

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Breast-conserving surgery for breast cancer An intended fractionation regimen of either 50 Gy in 25 fractions (conventional fractionation) or 40.05 Gy in 15 fractions (hypofractionation)

Exclusion criteria

Exclusion criteria: Different fractionation regimens Metastatic disease Neoadjuvant or concomitant chemotherapy Indication for regional nodal radiation treatment Previous radiation to the ipsilateral breast wall Breast reconstruction Mastectomy Previous operations in the irradiation area (e.g. bypass, pacemaker, etc.) Active dermatitis Any preexisting chronic dermatological disorders Treatment with topical or oral corticosteroids Tattoos in the irradiation area Patient refusal to participate

Design outcomes

Primary

Measure	Time frame
Maximum radiation dermatitis severity as assessed by gradings corresponding to the CTCAE v4.03 criteria and technical skin color measurements	—

Secondary

Measure	Time frame
Patient-reported symptoms	—

Countries

Germany, Switzerland

Contacts

Public ContactJennifer Beck

Universitätsklinikum BonnRadiologische KlinikSektion Strahlentherapie

jennifer.beck@ukbonn.de022828715253

Outcome results

None listed

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