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

Not Applicable

Completed

Conditions: Quality of Life
Radiodermatitis

Interventions: Device: Xonrid® gel
Other: Standard of Care

Registration Number: NCT03255980

Lead Sponsor: Helsinn Healthcare SA

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 80

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xonrid®	Standard of Care	Xonrid® is a medical device for radiation dermatitis
Xonrid®	Xonrid® gel	Xonrid® is a medical device for radiation dermatitis
Standard of Care	Xonrid® gel	Standard of care suggested by MASCC guidelines

Primary Outcome Measures

Name	Time	Method
Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5	5 weeks over 7 weeks	The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis \< G2) at week 5

Secondary Outcome Measures

Name	Time	Method
The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.	Follow-up: 2 weeks after the completion of radiation treatment	The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators.
Median Time to G2 Radiodermatitis Development	5 weeks over 7 weeks	Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation
The Mean and Worst Score of Skindex-16 Questionnaire	5 weeks over 7 weeks	Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16
The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale	6 weeks over 7 weeks	Global patient's satisfaction recorded by the Linkert Scale
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	5 weeks over 7 weeks	Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans
The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation	6 weeks over 7 weeks	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.
The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation	weekly during teratment (7 weeks)	Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema
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	5 weeks over 7 weeks	Compliance is based on the total amount ( weight) of Xonrid used over the treatment period