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

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.

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Radiodermatitis
• Intervention / Treatment: Device: Xonrid® gel; Other: Standard of Care

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20133
    • Fondazione IRCCS Istituto Nazionale dei Tumori

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xonrid®; Xonrid® is a medical device for radiation dermatitis	Device: Xonrid® gel; Water based gel for the management of toxicity skin symptoms induced by Radiotherapy; Other: Standard of Care; Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines
Active Comparator: Standard of Care; Standard of care suggested by MASCC guidelines	Device: Xonrid® gel; Water based gel for the management of toxicity skin symptoms induced by Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	5 weeks over 7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Time to G2 Radiodermatitis Development	Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation	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	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.	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.	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	weekly during teratment (7 weeks)
The Mean and Worst Score of Skindex-16 Questionnaire	Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16	5 weeks over 7 weeks
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	Compliance is based on the total amount ( weight) of Xonrid used over the treatment period	5 weeks over 7 weeks
The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale	Global patient's satisfaction recorded by the Linkert Scale	6 weeks over 7 weeks

Collaborators and Investigators

• Sponsor: Helsinn Healthcare SA
• Investigators: Principal Investigator: Orlandi Ester, MD, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2017
• Primary Completion (Actual): February 20, 2019
• Study Completion (Actual): January 22, 2020

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: August 16, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Radiation Injuries; Dermatitis; Radiodermatitis
• Other Study ID Numbers: HD01-16-30

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No