Clinical Trial to Evaluate Safety and Efficacy of Jalosome® Soothing Gel.

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.

Inclusion Criteria:

• Male and female subject aged ≥18 years old.
• Performance status 0-1.
• Diagnosis of HNC (epithelial carcinoma of oropharynx, nasopharynx, larynx, hypopharynx, paranasal sinuses or salivary glands).
• Postoperative or curative RT (total radiation dose of at least 60 Gy), with or without concurrent chemotherapy.
• Willingness and ability to give informed consent and comply with study procedures.

Exclusion Criteria:

• Pregnant or lactating women.
• Previous RT on the head and neck area.
• Planned to receive concurrent cetuximab.
• Cutaneous and/or connective diseases (i.e. lupus erythematosus or scleroderma).
• Systemic diseases known to delay the skin healing process, such as diabetes mellitus or severe renal failure.
• Use of a tissue-equivalent bolus.
• Use of over-the-counter topical medications containing steroids.
• Presence of rashes or unhealed wounds in the radiation field.
• Recent sun exposure (<1 month).
• Mental conditions that could adversely affect subject's adherence to the study.