Supervisors info:
Μιχαήλ Ράλλης
Επίκουρος Καθηγητής, Τομέας Φαρμακευτικής Τεχνολογίας, Τμήμα Φαρμακευτικής,
Σχολή Επιστημών Υγείας, Εθνικό και Καποδιστριακό Πανεπιστήμιο Αθηνών
Summary:
Non-melanoma skin cancer (NMSC) is the most common cancer worldwide, with Basal cell carcinoma (BCC) accounting for 70–80% of all cutaneous malignancies and squamous cell carcinoma (SCC) showing an increasing incidence over the past years by 50 and up to 200%. Radiotherapy represents a fair alternative to surgery in non-operable cases, usually due to tumour’s location on cosmetically sensitive areas or patient’s medical background. Radiation-induced dermatitis is an extremely common adverse event of radiotherapy, affecting more than 85% of people under treatment, causing much distress in their quality of life and making compliance to therapy hard to achieve. Despite the growing number of clinical trials, there is still no regimen fulfilling our needs and expectations in order to prevent such a disturbing side effect.
Based on encouraging preclinical evidence of long-term research on Pinus halepensis extract, conducted in Small Animal Laboratory of Pharmaceutical Technology Department of National and Kapodistrian University of Athens, a randomized, single-blinded, parallel group, clinical study was designed, that took place in Radiotherapy Department of Andreas Syggros Hospital of Cutaneous and Venereal Diseases. Purpose of this study was to examine effectiveness and safety of a gel containing Pinus halepensis extract and N-acetylcysteine, in order to prevent acute radiodermatitis in patients with non-melanoma skin cancer undergoing radiotherapy, as well as to compare its action with a commercially available medical device.
Twenty two patients that met inclusion criteria were randomly assigned to two groups, applying twice a day either pinus gel or control gel. Evaluation of radiation-induced skin reactions was made according to RTOG grading scale, patients reported outcomes and biophysical measurements, during radiotherapy time and one month afterwards.
Statistical analysis showed pinus gel to be more effective at ameliorating skin condition during the month after radiotherapy, preventing chronic inflammation, as well as at reducing subjective discomfort and achieving better scores in most measurements. No adverse event was reported in intervention group, indicating that pinus gel is a safe topical prophylactic treatment for radiodermatitis and future studies on greater sample size should be executed in order to confirm these results.
Keywords:
radiation-induced dermatitis,prevention,non-melanoma skin cancer,pinus halepensis extract
