Primary endpoint:~Mean time difference in development of G2 RID (according to CTCA) between Jalosome® and placebo arms. A median difference of at least 7 days is considered of clinical significance.~• Secondary endpoints:~Proportion of subjects without G2 RID at the end of RT, in the Jalosome® and placebo arms.~Proportion of subjects without G2 RID at different timepoints (week 5, week 6 and two weeks after the last radiation) in the Jalosome® and placebo arms.~Worst skin toxicity during treatment and up to 2 weeks after the last radiation, according to CTCAE, in the Jalosome® and placebo arms.~RID grade (mean and worst) on the RISRAS scale, assessed weekly, in the Jalosome® and placebo arms.~Mean and worst score of PRO-Skindex-16 questionnaire performed weekly, in the Jalosome® and placebo arms.~Mean pain measured by the 11-point NRS of the Brief Pain Inventory (BPI), as reported in patients' diary (daily) and assessed during visits (weekly), in the Jalosome® and placebo arms.~Patient's compliance to Jalosome® treatment.~Patient's global satisfaction with Jalosome® treatment.~Jalosome® overall safety and tolerability.~Study design:~Monocentric, randomized, double-blind, placebo controlled clinical trial.
Primary objective~- To investigate the effectiveness of Jalosome® compared with placebo in the prevention and treatment of RID in patients with HNC undergoing RT.~Secondary objectives:~To investigate the effectiveness of Jalosome® in reducing the maximum severity of RID compared with placebo.~To investigate the effect of Jalosome®, compared with placebo, on patients' quality of life.~To investigate safety and tolerability of Jalosome®.~To investigate patient's compliance to Jalosome® treatment.~To investigate patient's global satisfaction with Jalosome® treatment.