Randomized trial on the efficacy of two non steroidal drugs in the prevention of skin damage induced by radiotherapy

The aim of this study is to evaluate the reparative properties of the Restitutio Restructuring Cream (RRC) produced in two formulations for the skin injuries caused by radiation in patients undergoing radiotherapy treatment: "A formulation", cutaneous emulsion based on alginates; "B formulation", cutaneous emulsion based on alginates, hyaluronic acid, and beta-glucan. A total of 64 patients were recruited in the protocol: 52 patients with breast cancer operated on conservatively and requiring postoperative radiotherapy and 12 patients with head and neck cancer requiring curative radiotherapy. Patients were randomized to receive, during radiotherapy, a topical treatment with RRC on the irradiated skin. Overall 39 patients reported skin toxicity at grade 1. Grade 2 of skin toxicity was observed in only 6 patients with breast cancer. We have not observed any cases of grade 3 or more of skin toxicity requiring break in radiotherapy treatment. Results were assessed not only in terms of grade and overall reduction in toxicity but also in terms of full regression of skin lesions with "ad integrum restitutio" and in terms of rapidity of repair of radio-induced damage. Both formulations of cream used showed good effectiveness though better for "B formulation"; "ad integrum restitutio" was good and occurred on average within 5 and a half weeks.