Preemptive Treatment With XONRID to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients
Head and Neck Cancer
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring head neck cancer XONRID radiation induced dermatitis
Eligibility Criteria
Inclusion Criteria:
- > 18 years
- Performance status < 2
- Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands
- Planned to receive at least 50 Gy on one side of the neck with at least the 2nd level of neck nodes irradiated
- Postoperative or curative radiation treatment
- Concurrent platinum based chemotherapy is accepted, but not mandatory
- Conventional fractionation (1.8-2.12 GY per fraction, one daily fraction, 5 fractions a week )
Exclusion Criteria:
- Pregnant or lactating women
- Planned to receive concurrent cetuximab
- Previous radiation therapy on the head and neck area
- Cutaneous and connettive diseases (i.e. lupus erythematosus or scleroderma)
- Systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure.
- Use of a tissue-equivalent bolus
- Use of over-the-counter topical medications containing steroids
- Presence of rashes or unhealed wounds in the radiation field
- Recent sun exposure
- Mental conditions that could adversely affect patients' adherence to the study
Sites / Locations
- Fondazione IRCCS Istituto Nazionale Tumori
Arms of the Study
Arm 1
Experimental
XONRID
Patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients. Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines. The use of other topical medications for the treatment of dermatitis will be not permitted during the study.