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

Helsinn Healthcare SA80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Radiodermatitis Quality of Life

Interventions

Xonrid® gelDEVICE

Water based gel for the management of toxicity skin symptoms induced by Radiotherapy

Standard of CareOTHER

Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male and female which are 18 years of age or older 2. Performance status \< 2 3. 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 4. Postoperative or curative radiation treatment 5. Concurrent chemotherapy is accepted, in head \& neck cancer patients 6. 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: 1. Pregnant or lactating women 2. Planned to receive concurrent cetuximab 3. Previous radiation therapy on the head and neck area or breast and thorax areas 4. Cutaneous and connective diseases (i.e. lupus erythematosus or scleroderma) 5. Systemic diseases known to delay the skin healing process such as diabetes mellitus or severe renal failure 6. Use of a tissue-equivalent bolus 7. Use of over-the-counter topical medications containing steroids 8. Presence of rashes or unhealed wounds in the radiation field 9. Recent sun exposure 10. Mental conditions that could adversely affect patients' adherence to the study.

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Outcomes

Primary Outcomes

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

Time frame: 5 weeks over 7 weeks

Secondary Outcomes

Median Time to G2 Radiodermatitis Development

Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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

Data from ClinicalTrials.gov

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