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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on radiation-induced oral mucositis, a condition where the lining of the mouth becomes inflamed due to radiation therapy in patients with head and neck cancer. The study will test a mouth rinse containing dexpanthenol (Bepanthen® Solution) compared to placebo to determine if it can help prevent or reduce mouth inflammation during radiation treatment.

The purpose of the study is to evaluate how effective dexpanthenol solution is in reducing the severity of mouth inflammation compared to a placebo mouth rinse. During the study, participants will use either the dexpanthenol mouth rinse or placebo while receiving their regular radiation therapy. The treatment period will last about 9 weeks.

Throughout the study, healthcare providers will monitor various aspects of participants' health, including mouth discomfort, ability to taste food, breathing through the nose, swallowing ability, and overall quality of life. They will also track any side effects that may occur from the mouth rinse or radiation therapy. The total duration of the study is expected to be approximately three years.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    You will receive either Bepanthen® Solution or a placebo (water) as a mouth rinse during your radiation therapy for head and neck cancer

    The purpose is to evaluate if the mouth rinse can help reduce oral mucositis (mouth sores caused by radiation therapy)

  2. Step 2

    Treatment schedule

    You will use the assigned mouth rinse throughout your radiation therapy course

    The medical team will monitor the condition of your mouth using a standardized grading system

  3. Step 3

    Monitoring and assessments

    Regular checks will include:

    Assessment of mouth pain and difficulty swallowing

    Taste testing for sour, bitter, and salty flavors

    Measurement of nasal breathing and pressure

    Tracking of weight changes

    Evaluation of tiredness levels

  4. Step 4

    Quality of life assessment

    You will complete questionnaires about:

    Physical functioning and daily activities

    Emotional and social well-being

    Specific symptoms related to head and neck treatment

    Problems with eating, speaking, and swallowing

  5. Step 5

    Treatment completion

    Return of any unused mouth rinse bottles

    Final assessment of mouth condition

    Documentation of any side effects from the treatment

Who can join the trial?

6 criteria

  • Must be at least 18 years old
  • Must be able to provide written informed consent to participate in the trial
  • Must have a confirmed diagnosis of head and neck cancer requiring curative radiotherapy (treatment using radiation to eliminate cancer cells)
  • Must have a life expectancy of at least 6 months
  • Can be either male or female
  • Must have cancer that falls under specific medical classification codes (ICD-10 codes C00 to C14, C32, and C76), which include various types of head and neck cancers

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 75 years
  • Known allergies or hypersensitivity to dexpanthenol (the active ingredient) or any other components of the mouth rinse
  • Current participation in other clinical trials
  • Pregnancy or breastfeeding
  • Presence of active oral infections
  • History of head and neck surgery in the past 6 months
  • Serious medical conditions that could interfere with the study, such as uncontrolled diabetes (high blood sugar disease) or severe heart problems
  • Current use of other treatments for oral mucositis (mouth inflammation)
  • Unable to follow study instructions or attend scheduled visits
  • History of alcohol or drug abuse within the past year
  • Mental conditions that could affect the ability to provide informed consent
  • Use of tobacco products within 30 days before the study start
  • Presence of dental problems requiring immediate treatment
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Investigated drugs

Dexpanthenol (Bepanthen® Solution) is a mouth rinse medication that helps protect and heal the lining of the mouth. It is used to prevent and reduce mouth soreness (mucositis) that can occur as a side effect of radiation therapy. The solution works by supporting the natural healing process of mouth tissues and providing a protective coating to irritated areas. This medication is applied as a rinse, which means you swish it around in your mouth before spitting it out.

What is already known about the treatment

Dexpanthenol - An oral rinse solution used to prevent and treat radiation-induced oral mucositis, particularly in cancer patients undergoing radiation therapy. This medication is a provitamin of B5 (pantothenic acid) that helps promote healing of oral tissues and maintains the natural protective barrier of the mouth's mucous membranes. When used as a mouth rinse, dexpanthenol works by stimulating epithelial cell regeneration and supporting the natural healing process of damaged oral tissues. The substance belongs to the vitamin B family of compounds and is widely recognized in medical literature for its tissue-healing and protective properties.

Investigated diseases

Radiation-induced Oral Mucositis - A condition that develops as a side effect of radiation therapy to the head and neck area. It involves inflammation and ulceration of the mucous membranes lining the mouth and throat. The condition typically begins with redness and soreness of the mouth tissues, which can progress to painful ulcers. Patients may experience discomfort while eating, drinking, or speaking as the condition develops. The severity can range from mild inflammation to extensive ulceration of oral tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510522-32-00Protocol codeSTR-202301Estimated enrolment126 patientsSponsorRheinische Friedrich-Wilhelms-Universitaet Bonn

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