Letzte Aktualisierung: 06.05.2026

Kopf-Hals-Karzinom [C00-C14, C32]

MucPreDex

Aktive Studien

Studieninformationen

MucPreDex: Strahleninduzierte MUCositis-Prävention mit DEXpanthenol-Mundspülung

Behandlungszentren im CIO

Bonn


Ziele

Primäres Prüfziel

The primary objective of this trial is to assess potential effects of the administration of Bepanthen® Solution as mouth rinse (dexpanthenol solution) in the intensity of radiation-induced mucositis compared to placebo mouth rinse at Visit 8 (End of IMP treatment)

Sekundäre Prüfziele für die Behandlungsarme:

The secondary objectives of this trial are to assess potential effects of the administration of Bepanthen® Solution as mouth rinse (dexpanthenol solution), on the intensity of radiation-induced mucositis over time during radiotherapy and the Follow up phase (assessed at Visit 2 to Visit 10), on the occurrence of radiation-induced mucositis at all assessment points, on radiation-induced impairment of taste and smell tasting at all assessment points compared to placebo mouth rinse. Further secondary objectives are the evaluations whether the administration of Bepanthen® Solution as mouth rinse (dexpanthenol solution) improve or preserve quality of life (assessed by the trial personnel or from the subject's perspective) compared to placebo mouth rinse at all assessment points. Iluence subjects' contentment with and compliance to radiotherapy and IMP treatment compared to placebo mouth rinse at Visit 8 (End of treatment). Additionally, safety and tolerance of the IMP are evaluated as secondary endpoints during the clinic.


Design

Design

Phase

III

Zentren

Monozentrisch

Datenerhebung

Prospektiv

Interventionsgruppen

Zweiarmig

Verblindung

Doppelblind

Erkrankung

Diagnose

Kopf-Hals-Karzinom [C00-C14, C32]

Diagnosenbeschreibung

Male and female subjects with pathologically confirmed malignancy in the head and neck area and indication for radiotherapy.

Mutation

Patienten

Alter

18+ Jahre

Einschlusskriterien

1. Subjects male or female, aged ≥ 18 years 2. The subject has given written consent to participate in the clinical trial. 3. Subjects with a confirmed diagnosis of head and neck cancer and indication for a curative radiother apy. This includes the ICD-10 (International Statistical Classification Of Diseases And Related Health Problems, 10th revision)-Codes: C00 to C14, C32, and C76. Indication-specific inclusion criteria: 4. Subjects with a life expectancy of at least 6 months

Ausschlusskriterien

1. Subject without legal capacity who is unable to understand the nature, scope, significance and conse quences of this clinical trial, even if the subject has a legally acceptable representative 2. Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the trial results, or may interfere with the subject's participation in this clinical trial 3. Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investiga tional product, up to 30 days prior to participation in that clinical trial. 4. Reported history (within the last 12 months before screening) or persistent abuse of medication, abuse of drugs or alcohol misuse as assessed by the investigator considering participant's safety and adher ence to treatment 5. Known allergy/ incompatibility against Bepanthen® solution or dexpanthenol Indication specific exclusion criteria: 6. Subjects with a pre-irradiation in the neck area 7. Subjects under systemic corticosteroid therapy

Therapie

Intervention

Substanz

Zuständige Gesamtstudie

Sponsor

Leiter der klinischen Prüfung (LKP)

Studiengruppen/-zentrale

Kontakt Klinische Studien

CIO Aachen: Uniklinik RWTH Aachen, +49 (0) 241 80-85490

CIO Bonn: Uniklinik Bonn, +49 (0) 228 287-16036

CIO Köln: Uniklinik Köln, +49 (0) 221 478-0

CIO Düsseldorf: Uniklinik Düsseldorf, +49 (0) 211 81-04150 (Mo-Do)