Stomatitis Trials in Disease

Study of dexpanthenol mouth rinse for preventing radiation-induced oral mucositis in patients receiving radiotherapy

This clinical trial is investigating whether a dexpanthenol mouth rinse can help prevent or reduce mouth inflammation in patients receiving radiation therapy for head and neck cancer. The condition being studied, radiation-induced oral mucositis, occurs when the lining of the mouth becomes inflamed and develops painful sores as a side effect of radiation treatment.

Main inclusion criteria:

• Adults between 18 and 75 years old
• Confirmed diagnosis of head and neck cancer requiring curative radiotherapy
• Life expectancy of at least 6 months
• Ability to provide written informed consent
• Cancer types include those classified under specific medical codes covering various head and neck cancers

Main exclusion criteria:

• Known allergies to dexpanthenol or other components of the mouth rinse
• Pregnancy or breastfeeding
• Active oral infections
• Recent head and neck surgery within the past 6 months
• Serious medical conditions such as uncontrolled diabetes or severe heart problems
• Current use of other treatments for mouth inflammation
• Use of tobacco products within 30 days before starting the study
• Dental problems requiring immediate treatment
• History of alcohol or drug abuse within the past year

Focus and goal of the trial:

The primary goal of this study is to evaluate how effective dexpanthenol solution is in reducing the severity of mouth inflammation compared to a placebo mouth rinse. Participants will use either the dexpanthenol mouth rinse (Bepanthen® Solution) or a placebo throughout their radiation therapy course, which lasts approximately 9 weeks.

During the study, healthcare providers will closely monitor various aspects of participants' health and well-being. This includes assessing mouth pain and discomfort, ability to taste different flavors (sour, bitter, and salty), nasal breathing capacity, swallowing ability, weight changes, and levels of tiredness. Participants will also complete questionnaires about their physical functioning, daily activities, emotional and social well-being, and specific symptoms related to their treatment, such as problems with eating, speaking, and swallowing.

Regular checks will be performed using a standardized grading system to evaluate the condition of the mouth throughout the treatment period. The total duration of the study is expected to be approximately three years, although individual participation lasts about 9 weeks during the radiation therapy course.

Investigational drug:

The study is testing dexpanthenol (marketed as Bepanthen® Solution), a mouth rinse medication that helps protect and heal the lining of the mouth. Dexpanthenol is a provitamin of B5 (pantothenic acid) that promotes healing of oral tissues and maintains the natural protective barrier of the mouth's mucous membranes. When used as a mouth rinse, it works by stimulating the regeneration of cells lining the mouth and supporting the natural healing process of damaged tissues. The medication is applied by swishing it around in the mouth before spitting it out, providing a protective coating to irritated areas.