A monocentric, open-label randomized standard-of-care controlled study of XONRID®, a medical device for the prevention and treatment of radiation-induced dermatitis in breast and head and neck cancer patients

Abstract

Background: This study was an open-label, 2-arms, monocentric, randomized clinical trial comparing Xonrid®, a topical medical device, versus standard of care (SOC) in preventing and treating acute radiation dermatitis (ARD) in Head and Neck Cancer (HNC) and Breast Cancer (BC) patients undergoing radiotherapy (RT). Methods: Eligible HNC and BC patients were randomized 1:1 to receive Xonrid® + SOC or SOC during RT. Patients were instructed to apply Xonrid® on the irradiated area three times daily, starting on the first day of RT and until 2 weeks after RT completion or until the development of grade ≥ 3 skin toxicity. The primary endpoint was to evaluate the proportion of patients who developed an ARD grade < 2 at the 5th week in both groups. Secondary endpoints were median time to grade 2 (G2) skin toxicity onset; changes in skin erythema and pigmentation and trans-epidermal water loss (TEWL); patient-reported skin symptoms. All patients were evaluated at baseline, weekly during RT and 2 weeks after treatment completion. The evaluation included: clinical toxicity assessment; reflectance spectrometry (RS) and TEWL examination; measurement of patients' quality of life (QoL) through Skindex-16 questionnaire.

MASCC clinical practice guidelines for the prevention and management of acute radiation dermatitis: part 1) systematic review

“…Insufficient evidence was reported to support the use of urea, Xonrid, hydroactive colloid gel, and other interventions. 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 , 52 , 53 , 54 , 55 Topical corticosteroids 18 (15) 1715 (81; 12–219) Mometasone furoate (8); Betamethasone (6); Other (4) Breast (14); Head and neck (3); Multiple (1) Mometasone furoate and betamethasone were both generally found to be effective in ARD prevention. There is insufficient evidence supporting the use of other corticosteroids, such as hydrocortisone and beclomethasone.…”

Photobiomodulation therapy for the prevention of acute radiation dermatitis: a systematic review and meta-analysis

“…RT frequently causes impaired HRQoL and, especially in HNC patients, hindered functional ability [ 26 ]. The evaluation of patient-reported outcomes is becoming increasingly considered by physicians [ 27 ]. HRQoL in patients affected by RD following breast RT has been shown to be worse in severe grades and during advanced phases of RT [ 28 ].…”

Mexican radiation dermatitis management consensus

“…In agreement with SCoR [ 14 ], for the management of RD grade 3, the panel recommendation is the use of pharmacological products with drying effects. The panelists did not reach consensus for recommending a change to the medical device due to the scarcity of published evidence [ 23 , 24 ] on its efficacy and on its availability.…”

“…There are two studies supporting the action of the medical device with hyaluronic acid [ 23 , 24 ]. Iacovelli et al 2017 [ 23 ], a pilot study at the Referral Center for the Treatment and Management of Cancer, Milan, Italy, evaluated patients over the age of 18 with head and neck tumors with neck nodes inclusion who received > 50 Gy RT treatment.…”

“…The treatment with the medical device reduced the rate of cutaneous toxicity up to 20% in RT treated patients. 2) Ingargiola et al 2020 [ 24 ], in a unicenter-2 branch clinical setting, open labeling, randomized study, compared the medical device associated to a previous standard of care study vs a standard care only study, to prevent and treat acute RD in cancer of the head and neck, and breast cancer patients, undergoing RT. Patients were told to apply the medical device in the radiated area 3 times a day, beginning with the first day of RT and up to 2 weeks after completing the treatment or until grade 3 RD developed.…”