N/A
Completed N=80
Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®
Radiodermatitis · quality of life
Source: ClinicalTrials.gov NCT03255980 ↗
Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Dec 2020
Primary outcomePrimary: Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5 — 10; 5; 13; 11 participants
Summary
To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head & neck cancer patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5 |
10; 5; 13; 11 | — |
| SECONDARY Median Time to G2 Radiodermatitis Development |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation |
— | — |
| SECONDARY The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study. |
— | — |
| SECONDARY The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation |
— | — |
| SECONDARY The Mean and Worst Score of Skindex-16 Questionnaire |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03255980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.