Non-invasive physical plasma in the prevention and treatment of radiation dermatitis in breast cancer irradiation: a phase I-II trial

Non-invasive physical plasma in the prevention and treatment of radiation dermatitis in breast cancer irradiation: a phase I-II trial - NIPP-RD

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00026225

Enrollment

Registered

2021-09-28

Start date

2021-10-01

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: NIPP - non-invasive physical plasma Group 2: urea 5% lotion twice daily

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - whole-breast irradiation (WBI) - age > 18 years - breast-conserving surgery for breast cancer - fractionation regimen of 40.05 Gy in 15 fractions of 2.67 Gy - oral and written informed consent

Exclusion criteria

Exclusion criteria: - active smoking - metastatic disease - concomitant chemotherapy - breast reconstruction - alternative fractionation regimens - history of ipsilateral breast irradiation - any preexisting dermatological disorder - active dermatitis - current treatment with topical or oral corticosteroids - patient refusal to participate

Design outcomes

Primary

Measure	Time frame
Maximum radiation dermatitis severity as assessed by gradings corresponding to the CTCAE v5.0 criteria and technical skin colour measurements	—

Secondary

Measure	Time frame
Patient-reported symptoms (RISRAS)	—

Countries

Germany

Contacts

Public ContactCas Dejonckheere

Universitätsklinik für Strahlentherapie und Radioonkologie

cas.dejonckheere@ukbonn.de022828711241

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 10, 2026