MucPreDex: Radiation-induced MUCositis PREvention using DEXpanthenol mouth rinse

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

29 Aug 2025 → ongoing

Decision date (initial)

2024-10-30

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Bayer Vital GmbH

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Prophylaxis

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).

Secondary objectives 7

1. The secondary objectives of this trial are to assess potential effects of the administration of Bepanthen® Solution as mouth rinse (dexpanthenol solution) on the intensity of radiation-induced mucositis over time during radiotherapy and the Follow up phase (assessed at Visit 2 to Visit 10) compared to placebo mouth rinse.
2. to assess potential effects of the administration of Bepanthen® Solution as mouth rinse (dexpanthenol solution) on the occurrence of radiation-induced mucositis at all assessment points compared to placebo mouth rinse compared to placebo mouth rinse.
3. to assess potential effects of the administration of Bepanthen® Solution as mouth rinse (dexpanthenol solution) on radiation-induced impairment of taste and smell tasting at all assessment points compared to placebo mouth rinse.
4. Further secondary objectives are the evaluations whether the administration of Bepanthen® Solution as mouth rinse (dexpanthenol solution) improve or preserve quality of life (assessed by the trial personnel or from the subject’s perspective) compared to placebo mouth rinse at all assessment points.
5. the evaluations whether the administration of Bepanthen® Solution as mouth rinse (dexpanthenol solution) influence subjects’ contentment with and compliance to a) radiotherapy compared to placebo mouth rinse at Visit 8 (End of treatment).
6. the evaluations whether the administration of Bepanthen® Solution as mouth rinse (dexpanthenol solution) influence subjects’ contentment with and compliance to b) IMP treatment compared to placebo mouth rinse at Visit 8 (End of treatment).
7. Additionally, safety and tolerance of the IMP are evaluated as secondary endpoints during the clinical trial.

Conditions and MedDRA coding

radiation-induced oral mucositis

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Subjects male or female, aged ≥ 18 years
2. The subject has given written consent to participate in the clinical trial.
3. 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.
4. Subjects with a life expectancy of at least 6 months

Exclusion criteria 7

1. 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
2. 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
3. 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.
4. 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
5. Known allergy/ incompatibility against Bepanthen® solution or dexpanthenol
6. Subjects with a pre-irradiation in the neck area
7. Subjects under systemic corticosteroid therapy

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Grading of oral mucositis according to NCI CTCAE v5.0

Secondary endpoints 13

1. Grading of oral mucositis according to NCI CTCAE v5.0
2. Number of cases with oral mucositis
3. Gustometry score (including the taste qualities, sour, bitter, and salty)
4. the results of the rhinomanometry examination of nasal pressure (resistance coefficient between the nostril and the nasopharynx)
5. the results of the rhinomanometry examination of airflow during breathing per side
6. assessed by the trial personnel: Grading of Fatigue, oral pain, dysphagia, and weight loss according to NCI CTCAE v5.0
7. from the subject’s perspective: EORTC QLQ – C30 questionnaire: item scales (Dyspnoea, Insomnia, Appetite loss, Constipation, Diarrhoea, Financial difficulties), functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning), and symptom scales (Fatigue, Nausea and vomiting, pain)
8. from the subject’s perspective: EORTC QLQ–H&N43 questionnaire: item scales (Social contact, Swelling in the neck, Coughing, Neurological problems, Problems opening mouth, Weight loss, Problems with wound healing) and multi-item scales (Social eating, Body image, Pain in the mouth, Problems with senses, Fear of progression/Anxiety, Skin problems, Speech, Swallowing, Problems with teeth, Dry mouth and sticky saliva, Problems with shoulder)
9. a) radiotherapy: Proportion of patients, who prematurely terminate their radiation therapy or have delays in therapy fractions due to adverse effects associated with radiotherapy
10. a) radiotherapy: Percentage compliance of subjects with planned radiotherapy
11. b) IMP treatment: Number of unopened IMP bottles returned and opened IMP bottles returned with remaining content
12. Frequency and intensity of adverse reactions of the IMP
13. Frequency and intensity of collateral symptoms related to radiotherapy (expected radiation adverse events per NCI CTCAE v5.0)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Sponsor organisation

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Address

Venusberg-Campus 1, Venusberg Venusberg

City

Bonn

Postcode

53127

Country

Germany

Scientific contact point

Organisation

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Contact name

Davide Scafa

Public contact point

Organisation

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Contact name

Davide Scafa

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 6 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications