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To evaluate the performance of Xonrid® in the prevention and treatment of G2 radiation dermatitis in breast and head & neck cancer patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xonrid® | Experimental | Xonrid® is a medical device for radiation dermatitis |
|
| Standard of Care | Active Comparator | Standard of care suggested by MASCC guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xonrid® gel | Device | Water based gel for the management of toxicity skin symptoms induced by Radiotherapy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orlandi Ester, MD | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
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FPI: June 2017 LPO: July 2018
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| ID | Title | Description |
|---|---|---|
| FG000 | Breast Cancer Group: Xonrid+SOC | Patients treated with the device under evaluation and according to MASCC guidelines |
| FG001 | Breast Cancer Group: SOC | Patients treated with Standard of Care according to MASCC guidelines |
| FG002 | Head and Neck Cancer Group: Xonrid + SOC | H&N Patients treated with the device under evaluation and according to MASCC guidelines |
| FG003 | Head and Neck Cancer Group: SOC | H&N Cancer Patients treated with Standard of Care according to MASCC guidelines |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Descriptive statistics of all relevant variables were performed
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| ID | Title | Description |
|---|---|---|
| BG000 | Breast Cancer Group: Xonrid+SOC | Patients treated with the device under evaluation and according to MASCC guidelines |
| BG001 | Breast Cancer Group: SOC | Patients treated with Standard of Care according to MASCC guidelines |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | 5 weeks over 7 weeks |
|
13 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Breast Cancer: Xonrid® +SOC | Xonrid® is a medical device for radiation dermatitis Xonrid® gel: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy Standard of Care: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.1) | Systematic Assessment | Hypersensitivity |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear Infection | Infections and infestations | MedDRA (21.1) | Systematic Assessment | Infections - pathogen unspecified |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fabio Macchi | Helsinn Healthcare SA | 0041919852121 | fabio.macchi@helsinn.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 6, 2017 | Nov 18, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2018 | Nov 19, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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MONOCENTER, OPEN LABEL CLINICAL INVESTIGATION
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| Standard of Care | Other | Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines |
|
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 |
| Adverse Event |
|
| Lack of compliance to study or assessmen |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| BG002 | Head and Neck Cancer Group: Xonrid + SOC | H&N Patients treated with the device under evaluation and according to MASCC guidelines |
| BG003 | Head and Neck Cancer Group: SOC | H&N Cancer Patients treated with Standard of Care according to MASCC guidelines |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Caucasian |
|
| Region of Enrollment | Number | participants |
|
| Head and Neck Cancer Group: Xonrid + SOC |
H&N Patients treated with the device under evaluation and according to MASCC guidelines |
| OG003 | Head and Neck Cancer Group: SOC | H&N Cancer Patients treated with Standard of Care according to MASCC guidelines |
|
|
| Secondary | Median Time to G2 Radiodermatitis Development | Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation | Not Posted | 5 weeks over 7 weeks | Participants |
| 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 | Definition of RD grade according to CTCAE v4.0 Scale by trained physicinans | Not Posted | 5 weeks over 7 weeks | Participants |
| Secondary | 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. | Not Posted | 6 weeks over 7 weeks | Participants |
| Secondary | 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. | Not Posted | Follow-up: 2 weeks after the completion of radiation treatment | Participants |
| Secondary | 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 | Not Posted | weekly during teratment (7 weeks) | Participants |
| Secondary | 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 | Not Posted | 5 weeks over 7 weeks | Participants |
| 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 | Compliance is based on the total amount ( weight) of Xonrid used over the treatment period | Not Posted | 5 weeks over 7 weeks | Participants |
| Secondary | The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale | Global patient's satisfaction recorded by the Linkert Scale | Not Posted | 6 weeks over 7 weeks | Participants |
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| 20 |
| 1 |
| 20 |
| 1 |
| 20 |
| EG001 | Breast Cancer: Standard Of Care | Standard of care suggested by MASCC guidelines | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | Head and Neck Cancer: Xonrid + SOC | Xonrid® is a medical device for radiation dermatitis Xonrid® gel: Water based gel for the management of toxicity skin symptoms induced by Radiotherapy Standard of Care: Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines | 0 | 20 | 0 | 20 | 0 | 20 |
| EG003 | Head and Neck Cancer: Standard of Care | Standard of care suggested by MASCC guidelines | 0 | 20 | 0 | 20 | 0 | 20 |
|
|
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| D014947 |
| Wounds and Injuries |