Radiation-induced Dermatitis Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel in the Prevention and Treatment of Radiation-induced Dermatitis in Patients With Head and Neck Cancer.
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.
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. ;
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