NCT02261181

Preemptive Treatment With XONRID to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients

Preemptive Treatment With XONRID a Medical Device to Reduce Radiation Induced Dermatitis in Head and Neck Cancer Patients Receiving Curative Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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 (1.8-2.12 Gy/die). 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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DEVICE	XONRID	The patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients. Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines.

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-07-01
• Completion: 2019-01-01
• First posted: 2014-10-10
• Last updated: 2021-09-29

Locations

1 site across 1 country: Italy