Status:
COMPLETED
Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®
Lead Sponsor:
Helsinn Healthcare SA
Conditions:
Radiodermatitis
Quality of Life
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients.
Detailed Description
The aim of this clinical investigation is to evaluate if the use of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head \& neck cancer patients can be a valid support...
Eligibility Criteria
Inclusion
- Male and female which are 18 years of age or older
- Performance status \< 2
- Epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinus and salivary glands or breast cancer, planned to receive a total dose of at least 50 Gy
- Postoperative or curative radiation treatment
- Concurrent chemotherapy is accepted, in head \& neck cancer patients
- Patients willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the Clinical Investigation Plan tests and procedures.
Exclusion
- Pregnant or lactating women
- Planned to receive concurrent cetuximab
- Previous radiation therapy on the head and neck area or breast and thorax areas
- Cutaneous and connective 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 :
June 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03255980
Start Date
June 15 2017
End Date
January 22 2020
Last Update
December 16 2020
Active Locations (1)
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1
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133