Ignite Creation Date:
2024-05-06 @ 3:21 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02261181
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2014-09-01
Brief Title:
Preemptive Treatment With XONRID to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients
Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Organization:
Fondazione IRCCS Istituto Nazionale dei Tumori Milano
Study Overview
Official Title:
Preemptive Treatment With XONRID a Medical Device to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients Receiving Curative Treatment
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is a strong need to study products with a preemptive role in radiation dermatitis development with a trial design taking in account patient subjective evaluation and compliance
XONRID is a promising device for radiation high grade dermatitis prevention it is a topical gel that prevents and treats skin symptoms such as erythema itching burning sensation and pruritus induced by radiotherapy or other causes
XONRID is a promising device for radiation high grade dermatitis prevention it is a topical gel that prevents and treats skin symptoms such as erythema itching burning sensation and pruritus induced by radiotherapy or other causes
Detailed Description:
The patients will be treated with XONRID standard of care SOC preemptive treatment adopted during radiation treatment for head and neck cancer patients in the Institution
Patients will be planned to receive Intensity-Modulated Radiotherapy Techniques IMRT or volumetric modulated radiotherapy VMAT with conventional fractionation at total dose of 50-66 GY in postoperative setting and 66-70 Gy in radical setting Radiotherapy will be planned with simultaneous boost SIB approaches using conventional fractionation 18-212 Gydie According to histology stage and pathology reports patients could receive concomitant platinum based chemotherapy
The patients will be evaluated at baseline at weekly intervals during RT and six months after treatment completion by 2 different treating physicians for each visit The evaluation will consist of a physician-assessed toxicity assessment using the Radiation Therapy Oncology Group RTOG and patient-reported outcome measured using the Skindex-16 questionnaire
In addition objective in vivo measurements of skin erythema and pigmentation based on reflectance spectrometry RS will be performed
Measurements will be performed before RT every 5 RT fractions once a week up to the end of RT and 6 months after RT completion same timing as clinical evaluation Instrumental RS measurement will be performed at five different fixed regions within the area treated with RT in any cases only on flat skin regions of the neck in an area corresponding to the second node level and in absence of hair or nevus
Patients will be planned to receive Intensity-Modulated Radiotherapy Techniques IMRT or volumetric modulated radiotherapy VMAT with conventional fractionation at total dose of 50-66 GY in postoperative setting and 66-70 Gy in radical setting Radiotherapy will be planned with simultaneous boost SIB approaches using conventional fractionation 18-212 Gydie According to histology stage and pathology reports patients could receive concomitant platinum based chemotherapy
The patients will be evaluated at baseline at weekly intervals during RT and six months after treatment completion by 2 different treating physicians for each visit The evaluation will consist of a physician-assessed toxicity assessment using the Radiation Therapy Oncology Group RTOG and patient-reported outcome measured using the Skindex-16 questionnaire
In addition objective in vivo measurements of skin erythema and pigmentation based on reflectance spectrometry RS will be performed
Measurements will be performed before RT every 5 RT fractions once a week up to the end of RT and 6 months after RT completion same timing as clinical evaluation Instrumental RS measurement will be performed at five different fixed regions within the area treated with RT in any cases only on flat skin regions of the neck in an area corresponding to the second node level and in absence of hair or nevus
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None