Status:
COMPLETED
Preemptive Treatment With XONRID to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
There is a strong need to study products with a preemptive role in radiation dermatitis development, with a trial design taking in account patient subjective evaluation and compliance. XONRID is a pr...
Detailed Description
The patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients in the Institution. Patients will be planne...
Eligibility Criteria
Inclusion
- \> 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2019
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02261181
Start Date
January 1 2015
End Date
January 1 2019
Last Update
September 29 2021
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale Tumori
Milan, Italy, 20133