Evaluation of Dexpanthenol Mouth Rinse for the Prevention of Radiation-Induced Oral Mucositis in Patients Undergoing Radiotherapy

The primary objective of this clinical trial is to evaluate the potential effects of administering **Bepanthen® Solution** as a mouth rinse, containing **dexpanthenol**, on the intensity of **radiation-induced oral mucositis** compared to a placebo mouth rinse at the end of the investigational medicinal product (IMP) treatment. This is clinically relevant as radiation-induced oral mucositis is a common and debilitating side effect of radiotherapy, impacting patient comfort and treatment adherence.

Secondary objectives include:

• Assessing the effects of Bepanthen® Solution on the intensity of radiation-induced mucositis over time during radiotherapy and the follow-up phase compared to placebo.
• Evaluating the occurrence of radiation-induced mucositis at all assessment points compared to placebo.
• Investigating the impact on radiation-induced impairment of taste and smell at all assessment points compared to placebo.
• Determining whether Bepanthen® Solution improves or preserves quality of life compared to placebo.
• Evaluating the influence on subjects' contentment with and compliance to radiotherapy and IMP treatment compared to placebo at the end of treatment.
• Assessing the safety and tolerance of the IMP during the clinical trial.

The clinical trial involves participants diagnosed with **radiation-induced oral mucositis**. The study population includes both male and female subjects aged 18 years and older, with a confirmed diagnosis of head and neck cancer, and an indication for curative radiotherapy. Participants are required to have a life expectancy of at least six months. The trial does not specify the total number of participants, as the sponsor has not provided this information. The selection criteria include individuals who have given written consent to participate. The trial population is characterized by a diverse age range and includes both genders. Participants are expected to be in a general health status that allows for the completion of the study, with no specific lifestyle considerations such as diet or physical activity mentioned. The trial includes a vulnerable population, indicating that special considerations may be in place to ensure the safety and ethical treatment of participants.

The clinical trial is designed to evaluate the efficacy of **dexpanthenol** mouth rinse in preventing radiation-induced oral mucositis. This is a randomized, double-blind, controlled trial comparing the effects of Bepanthen® Solution to a placebo. The trial is categorized as a Phase III study and is considered low intervention. The estimated duration of the trial is from December 2, 2024, to December 1, 2027. Participants will be involved for a maximum treatment period of 63 days, with a maximum daily dose of 40 ml and a total dose not exceeding 2520 ml.

The sequence of study visits includes an initial screening visit to confirm eligibility based on criteria such as age (≥18 years), a confirmed diagnosis of head and neck cancer, and a life expectancy of at least six months. Following the screening, participants will undergo regular follow-up visits to monitor the grading of oral mucositis according to NCI CTCAE v5.0, assess secondary endpoints such as gustometry scores, and evaluate the results of rhinomanometry examinations. The end-of-study visit will occur at the conclusion of the investigational medicinal product (IMP) treatment, where the primary objective is to assess the intensity of mucositis compared to the placebo group.

Participants may be subject to early termination from the study if they experience adverse effects that necessitate discontinuation of the investigational product or if they withdraw consent. The trial will also monitor compliance with planned radiotherapy and the frequency and intensity of adverse reactions to the IMP. The study aims to provide comprehensive data on the effectiveness of the **dexpanthenol** solution in reducing the severity of oral mucositis in patients undergoing radiotherapy for head and neck cancer.

The clinical trial involves the administration of **Bepanthen® Lösung 50 mg/ml Lösung**, a cutaneous solution containing the active substance **dexpanthenol**. This experimental medication is utilized as a mouth rinse to evaluate its efficacy in preventing radiation-induced mucositis. The pharmaceutical form of the medication is a cutaneous solution, and it is administered via **oromucosal use**. The dosage regimen includes a maximum daily dose of 40 ml, with a total maximum dose of 2520 ml over a treatment period of 63 days. The solution is manufactured by Bayer Vital GmbH and is identified by the marketing authorization number 6028978.00.00. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the treatment protocol.

The study also includes a **placebo** treatment, referred to as **Aqua conservata**. This non-experimental treatment serves as a comparator to the Bepanthen® Lösung. The placebo is administered in the same manner as the experimental medication, ensuring that any observed effects can be attributed to the active substance, **dexpanthenol**, rather than the administration process itself. The placebo is utilized to maintain the integrity of the trial's double-blind design, allowing for an unbiased assessment of the experimental treatment's efficacy.

Efficacy in the clinical trial titled "MucPreDex: Radiation-induced MUCositis PREvention using DEXpanthenol mouth rinse" will be assessed primarily through the grading of **oral mucositis** according to the NCI CTCAE v5.0 at Visit 8, which marks the end of the investigational medicinal product (IMP) treatment. Secondary efficacy endpoints include additional grading of oral mucositis, the number of cases with oral mucositis, and various patient-reported outcomes and clinical assessments. These include gustometry scores for taste qualities, results from rhinomanometry examinations of nasal pressure and airflow, and assessments of fatigue, oral pain, dysphagia, and weight loss, all evaluated according to NCI CTCAE v5.0.

Patient-reported outcomes will be collected using the EORTC QLQ-C30 and EORTC QLQ-H&N43 questionnaires, which cover a range of functional, symptom, and item scales. The trial will also monitor the proportion of patients who prematurely terminate or delay their radiotherapy due to adverse effects, compliance with planned radiotherapy, and the frequency and intensity of adverse reactions to the IMP. The collection and analysis of these efficacy parameters will be conducted at specified timepoints throughout the trial, ensuring a comprehensive evaluation of the treatment's impact on radiation-induced mucositis and related symptoms.