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MucPreDex: Radiation-induced MUCositis PREvention using DEXpanthenol mouth rinse
EU CTIS ID: 2023-510522-32-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subjects male or female, aged ≥ 18 years
- The subject has given written consent to participate in the clinical trial.
- Subjects with a confirmed diagnosis of head and neck cancer and indication for a curative radiotherapy. This includes the ICD-10 (International Statistical Classification Of Diseases And Related Health Problems, 10th revision)-Codes: C00 to C14, C32, and C76.
- Subjects with a life expectancy of at least 6 months
You likely can't join if
- Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial, even if the subject has a legally acceptable representative
- 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
- Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investigational product, up to 30 days prior to par-ticipation in that clinical trial.
- 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 adherence to treatment
- Known allergy/ incompatibility against Bepanthen® solution or dexpanthenol
- Subjects with a pre-irradiation in the neck area
See the full eligibility criteria
- Subjects male or female, aged ≥ 18 years
- The subject has given written consent to participate in the clinical trial.
- Subjects with a confirmed diagnosis of head and neck cancer and indication for a curative radiotherapy. This includes the ICD-10 (International Statistical Classification Of Diseases And Related Health Problems, 10th revision)-Codes: C00 to C14, C32, and C76.
- Subjects with a life expectancy of at least 6 months
- Subject without legal capacity who is unable to understand the nature, scope, significance and consequences of this clinical trial, even if the subject has a legally acceptable representative
- 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
- Simultaneous participation in another clinical trial, or participation in a clinical trial taking an investigational product, up to 30 days prior to par-ticipation in that clinical trial.
- 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 adherence to treatment
- Known allergy/ incompatibility against Bepanthen® solution or dexpanthenol
- Subjects with a pre-irradiation in the neck area
- Subjects under systemic corticosteroid therapy
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.