Quality of Life, Radiodermatitis
Conditions
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.
Interventions
DEVICEXonrid® gel
Water based gel for the management of toxicity skin symptoms induced by Radiotherapy
OTHERStandard of Care
Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines
Sponsors
Helsinn Healthcare SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
MONOCENTER, OPEN LABEL CLINICAL INVESTIGATION
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5 | 5 weeks over 7 weeks | The primary endpoint of this clinical investigation was the proportion of patients without G2 radiation dermatitis (radiation dermatitis \< G2) at week 5 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 5 weeks over 7 weeks | 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 | 6 weeks over 7 weeks | 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. | Follow-up: 2 weeks after the completion of radiation treatment | The changes in skin erythema and pigmentation, according to the ITA (individual Typological Angle) degrees measured throughout the study by the Investigators. |
| Median Time to G2 Radiodermatitis Development | 5 weeks over 7 weeks | Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation |
| The Mean and Worst Score of Skindex-16 Questionnaire | 5 weeks over 7 weeks | 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 | 5 weeks over 7 weeks | 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 | 6 weeks over 7 weeks | Global patient's satisfaction recorded by the Linkert Scale |
| The Changes in Trans-epidermal Water Loss (TEWL) Assessed Through the Evaporation | weekly during teratment (7 weeks) | Changes of skin characteristics in terms of TEWL according to the progression of the Radiotherapy and consequent erythema |
Countries
Italy
Participant flow
Recruitment details
FPI: June 2017 LPO: July 2018
Participants by arm
| Arm | Count |
|---|---|
| Breast Cancer Group: Xonrid+SOC Patients treated with the device under evaluation and according to MASCC guidelines | 20 |
| Breast Cancer Group: SOC Patients treated with Standard of Care according to MASCC guidelines | 20 |
| Head and Neck Cancer Group: Xonrid + SOC H&N Patients treated with the device under evaluation and according to MASCC guidelines | 20 |
| Head and Neck Cancer Group: SOC H&N Cancer Patients treated with Standard of Care according to MASCC guidelines | 20 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 0 | 1 |
| Overall Study | Grade =>3 Skin Toxicity | 1 | 4 | 6 | 5 |
| Overall Study | Lack of compliance to study or assessmen | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 | 3 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 3 |
Baseline characteristics
| Characteristic | Breast Cancer Group: Xonrid+SOC | Breast Cancer Group: SOC | Head and Neck Cancer Group: Xonrid + SOC | Head and Neck Cancer Group: SOC | Total |
|---|---|---|---|---|---|
| Age, Continuous | 49.56 years STANDARD_DEVIATION 4.8 | 49.01 years STANDARD_DEVIATION 4.54 | 55.73 years STANDARD_DEVIATION 12.46 | 59.49 years STANDARD_DEVIATION 12.34 | 53.45 years STANDARD_DEVIATION 8.52 |
| Race/Ethnicity, Customized | 20 Caucasian | 20 Caucasian | 20 Caucasian | 20 Caucasian | 80 Caucasian |
| Region of Enrollment Italy | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants |
| Sex: Female, Male Female | 20 Participants | 20 Participants | 4 Participants | 4 Participants | 48 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 1 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 1 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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
Time frame: 5 weeks over 7 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Breast Cancer Group: Xonrid+SOC | Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5 | 10 participants |
| Breast Cancer Group: SOC | Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5 | 5 participants |
| Head and Neck Cancer Group: Xonrid + SOC | Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5 | 13 participants |
| Head and Neck Cancer Group: SOC | Proportion of Patients Without Grade G2 Skin Toxicity Radiodermatitis at Week 5 | 11 participants |
Secondary
Median Time to G2 Radiodermatitis Development
Skin toxicity assessed accoriding to CTCAE v4.0 Term Dermatitis Radiation
Time frame: 5 weeks over 7 weeks
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.
Time frame: Follow-up: 2 weeks after the completion of radiation treatment
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
Time frame: weekly during teratment (7 weeks)
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
Time frame: 5 weeks over 7 weeks
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
Time frame: 5 weeks over 7 weeks
Secondary
The Patients' Global Satisfaction With Treatment, Assessed by Likert Scale
Global patient's satisfaction recorded by the Linkert Scale
Time frame: 6 weeks over 7 weeks
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
Time frame: 5 weeks over 7 weeks
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.
Time frame: 6 weeks over 7 weeks