Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®

Study Overview
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Brief Summary
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To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head & neck cancer patients.

Detailed Description
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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, when compared to the Standard of Care as defined by MASCC (Multinational Association for Supportive Care in Cancer) guidelines.

Official Title
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Monocenter, Open Label Clinical Investigation on the Treatment With Xonrid®, a Medical Device for the Prevention and Treatment of Radiotherapy-induced Dermatitis, in Breast and Head & Neck Cancer Patients Receiving Curative Treatment.

Conditions
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Radiodermatitis, Quality of Life

Intervention / Treatment
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* Device: Xonrid® gel
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: MONOCENTER, OPEN LABEL CLINICAL INVESTIGATION
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xonrid®<br>Xonrid® is a medical device for radiation dermatitis | Device: Xonrid® gel<br>* Water based gel for the management of toxicity skin symptoms induced by Radiotherapy<br>Other: Standard of Care<br>* Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines<br>|
| Active Comparator: Standard of Care<br>Standard of care suggested by MASCC guidelines | Device: Xonrid® gel<br>* Water based gel for the management of toxicity skin symptoms induced by Radiotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5 | The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis < G2) at week 5 | 5 weeks over 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Time to G2 Radiodermatitis Development | Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation | 5 weeks over 7 weeks | 
| The Proportion of Patients Without G2 Radiation Dermatitis at Week 6 for Both Cancer Sites, at Week 7 for Head & Neck Cancer and 2 Weeks After the Last Radiation for Both Cancer Sites | Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans | 5 weeks over 7 weeks | 
| The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation | Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation for both cancer sites, at week 7 for head & neck cancer and 2 weeks after the last radiation for both cancer sites. | 6 weeks over 7 weeks | 
| The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study. | The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators. | Follow-up: 2 weeks after the completion of radiation treatment | 
| The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation | Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema | weekly during teratment (7 weeks) | 
| The Mean and Worst Score of Skindex-16 Questionnaire | Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16 | 5 weeks over 7 weeks | 
| The Compliance to Experimental Treatment, Assessed Through the Number of Daily Product Applications Reported on the Patient's Diary, Compared to the Amount of Used Product | Compliance is based on the total amount ( weight) of Xonrid used over the treatment period | 5 weeks over 7 weeks | 
| The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale | Global patient's satisfaction recorded by the Linkert Scale | 6 weeks over 7 weeks |