Back to resultsMonocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®
Primary Purpose
Radiodermatitis, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Xonrid® gel
Standard of Care
Sponsored by
About this trial
This is an interventional other trial for Radiodermatitis
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.
Sites / Locations
- Fondazione IRCCS Istituto Nazionale dei Tumori
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Xonrid®
Standard of Care
Arm Description
Xonrid® is a medical device for radiation dermatitis
Standard of care suggested by MASCC guidelines
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Median Time to G2 Radiodermatitis Development
Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation
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
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.
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.
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
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
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
The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale
Global patient's satisfaction recorded by the Linkert Scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03255980
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2017 (Actual)
Primary Completion Date
February 20, 2019 (Actual)
Study Completion Date
January 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helsinn Healthcare SA
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiodermatitis, Quality of Life
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
MONOCENTER, OPEN LABEL CLINICAL INVESTIGATION
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Xonrid®
Arm Type
Experimental
Arm Description
Xonrid® is a medical device for radiation dermatitis
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard of care suggested by MASCC guidelines
Intervention Type
Device
Intervention Name(s)
Xonrid® gel
Intervention Description
Water based gel for the management of toxicity skin symptoms induced by Radiotherapy
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines
Primary Outcome Measure Information:
Title
Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5
Description
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 Outcome Measure Information:
Title
Median Time to G2 Radiodermatitis Development
Description
Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation
Time Frame
5 weeks over 7 weeks
Title
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
Description
Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans
Time Frame
5 weeks over 7 weeks
Title
The Worst Skin Toxicity During Treatment and Until 2 Weeks After the Last Radiation
Description
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
Title
The Changes in Skin Erythema and Pigmentation, According to the ITA (Individual Typological Angle) Degrees Measured Throughout the Study.
Description
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
Title
The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation
Description
Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema
Time Frame
weekly during teratment (7 weeks)
Title
The Mean and Worst Score of Skindex-16 Questionnaire
Description
Evaluate the patient's QoL changes occurred during the RT trough the validated self-assessed questionnaire Skindex-16
Time Frame
5 weeks over 7 weeks
Title
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
Description
Compliance is based on the total amount ( weight) of Xonrid used over the treatment period
Time Frame
5 weeks over 7 weeks
Title
The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale
Description
Global patient's satisfaction recorded by the Linkert Scale
Time Frame
6 weeks over 7 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orlandi Ester, MD
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milan
ZIP/Postal Code
20133
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Monocenter, Open Label Clinical Investigation on the Treatment of Radiation Induced Dermatitis With Xonrid®
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