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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	02.12.2024

Trial locations

Investigated drugs:

Dexpanthenol

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.

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 ID:

2023-510522-32-00

Protocol code:

STR-202301

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?