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

Helsinn Healthcare

Status: Completed

Conditions: Quality of Life; Radiodermatitis

Treatments: Device: Xonrid® gel; Other: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT03255980

HD01-16-30

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Xonrid®

Experimental group

Description:

Xonrid® is a medical device for radiation dermatitis

Treatment:

Device: Xonrid® gel

Other: Standard of Care

Standard of Care

Active Comparator group

Description:

Standard of care suggested by MASCC guidelines

Treatment:

Device: Xonrid® gel