Clinical trial NCT03255980: Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiodermatitis
Quality of Life
Lead sponsor: Helsinn Healthcare SA
Sponsor class: INDUSTRY
First posted: 2017-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: MONOCENTER, OPEN LABEL CLINICAL INVESTIGATION
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5
timeFrame: 5 weeks over 7 weeks
Secondary outcomes:
measure: Median Time to G2 Radiodermatitis Development
timeFrame: 5 weeks over 7 weeks
measure: 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
timeFrame: 5 weeks over 7 weeks
measure: The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation
timeFrame: 6 weeks over 7 weeks
measure: The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.
timeFrame: Follow-up: 2 weeks after the completion of radiation treatment
measure: The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation
timeFrame: weekly during teratment (7 weeks)
measure: The Mean and Worst Score of Skindex-16 Questionnaire
timeFrame: 5 weeks over 7 weeks
measure: 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
timeFrame: 5 weeks over 7 weeks
measure: The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale
timeFrame: 6 weeks over 7 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
name: Orlandi Ester, MD
role: PRINCIPAL_INVESTIGATOR
References: