DEXPANTHENOL for Radiation-induced oral mucositis | Head and neck cancer

Inclusion criteria

• {"criterion_text":"- Subjects male or female, aged ≥ 18 years\n- The subject has given written consent to participate in the clinical trial.\n- 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.\n- Subjects with a life expectancy of at least 6 months"}

Exclusion criteria

• {"criterion_text":"- 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\n- 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\n- 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.\n- 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\n- Known allergy/ incompatibility against Bepanthen® solution or dexpanthenol\n- Subjects with a pre-irradiation in the neck area\n- Subjects under systemic corticosteroid therapy"}

Primary endpoints

• {"endpoint_text":"- Grading of oral mucositis according to NCI CTCAE v5.0","definition_or_measurement_approach":"Grading performed according to NCI CTCAE v5.0; primary assessment at Visit 8 (End of IMP treatment) as described in main objective."}

Secondary endpoints

• {"endpoint_text":"- Grading of oral mucositis according to NCI CTCAE v5.0","definition_or_measurement_approach":"Grading according to NCI CTCAE v5.0 at multiple assessment points (Visit 2 to Visit 10)."}
• {"endpoint_text":"- Number of cases with oral mucositis","definition_or_measurement_approach":"Count of subjects meeting criteria for oral mucositis at assessment points."}
• {"endpoint_text":"- Gustometry score (including the taste qualities, sour, bitter, and salty)","definition_or_measurement_approach":"Gustometry testing including specified taste qualities."}
• {"endpoint_text":"- the results of the rhinomanometry examination of nasal pressure (resistance coefficient between the nostril and the nasopharynx)","definition_or_measurement_approach":"Rhinomanometry measuring nasal pressure/resistance coefficient per nostril."}
• {"endpoint_text":"- the results of the rhinomanometry examination of airflow during breathing per side","definition_or_measurement_approach":"Rhinomanometry measurement of airflow per side during breathing."}
• {"endpoint_text":"- assessed by the trial personnel: Grading of Fatigue, oral pain, dysphagia, and weight loss according to NCI CTCAE v5.0","definition_or_measurement_approach":"Investigator-assessed grading of listed symptoms per NCI CTCAE v5.0."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Patient-reported outcomes collected using the EORTC QLQ-C30 questionnaire."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Patient-reported outcomes collected using the EORTC QLQ-H&N43 questionnaire."}
• {"endpoint_text":"- a) radiotherapy: Proportion of patients, who prematurely terminate their radiation therapy or have delays in therapy fractions due to adverse effects associated with radiotherapy","definition_or_measurement_approach":"Proportion of subjects with premature termination or delays in planned radiotherapy due to radiotherapy-associated adverse effects."}
• {"endpoint_text":"- a) radiotherapy: Percentage compliance of subjects with planned radiotherapy","definition_or_measurement_approach":"Measured as percentage compliance with planned radiotherapy schedule."}
• {"endpoint_text":"- b) IMP treatment: Number of unopened IMP bottles returned and opened IMP bottles returned with remaining content","definition_or_measurement_approach":"Counting unopened and opened returned IMP bottles to assess compliance."}
• {"endpoint_text":"- Frequency and intensity of adverse reactions of the IMP","definition_or_measurement_approach":"Assessment and reporting of adverse reactions related to the IMP (frequency and intensity)."}
• {"endpoint_text":"- Frequency and intensity of collateral symptoms related to radiotherapy (expected radiation adverse events per NCI CTCAE v5.0)","definition_or_measurement_approach":"Assessment of expected radiation adverse events per NCI CTCAE v5.0 (frequency and intensity)."}

Germany

Earliest CTIS Part Ii Submission Date

09-10-2024

Latest Decision Or Authorization Date

29-09-2025

Processing Time Days

355

Number Of Sites

1

Number Of Participants

126

Primary sponsor

Full Name

Rheinische Friedrich-Wilhelms-Universitaet Bonn

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"Germany","full_name":"Universitaetsklinikum Bonn AöR","duties_or_roles":["1","10","11","12","13","14","5","6","7","8","9"],"organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Germany","full_name":"Bayer Vital GmbH","duties_or_roles":"Source of monetary support","organisation_type":"Pharmaceutical company"}