ASCO 2018-MELATONIN GEL FOR ORAL MUCOSITIS

Data from a phase II trial of Mucomel (3% melatonin gel) suggest the formulation may reduce the risk of oral mucositis resulting from chemo and radiotherapy for head and neck cancers.

"The reduction of duration of severe mucositis in the Mucomel arm with both Cisplatin and Cetuximab is clinically relevant and could impact in quality of life," senior author Dr. Ricard Mesia, head of medical oncology at the Institut Catala d'Oncologia in Badalona, Spain, told Reuters Health.

Dr. Mesia and colleagues presented their findings June 3rd at the American Society of Clinical Oncology's annual conference in Chicago.

The researchers tested Mucomel in a randomized trial in 84 patients who were receiving high dose radiation (median 70 Gy) and concurrent chemotherapy. Fifty-four patients (64%) were being treated with cisplatin and 30 (36%) with cetuximab.

Half of the patients applied Mucomel oral gel five times a day during the course of treatment, while the remaining half applied a placebo oral gel.

All patients received standard treatment for symptoms of oral mucositis.

The incidence of severe oral mucositis - as defined by Radiation Therapy Oncology Group (RTOG) and National Cancer Institute (NCI) criteria - was lower in the study group at 57% compared to 79% in the placebo group (p=0.05).

Furthermore, median duration of ulcerative oral mucositis was lower at 39 days with active treatment compared to 58 days with placebo (p=0.004), according to the NCI scale. The difference approached significance according to the RTOG scale (p=0.06). But there was no significant difference in duration of severe oral mucositis.

The benefits were largely driven by the improved results in the cisplatin-treated patients. In that group, the incidence of severe oral mucositis was 44% in the treatment arm compared to 78% with placebo, according to a combined analysis of the RTOG and NCI scales (p=0.02). Cisplatin-treated patients also had a shorter median duration of ulcerative oral mucositis with the gel, at 35 days, compared to 52 days in the placebo arm (p=0.03) according to the NCI scale. The pattern was similar with the RTOG scale.

The findings are interesting but need validation in a larger cohort, said Dr. Venkatraman Radhakrishnan, Associate Professor of Medical Oncology at the Cancer Institute in Chennai, India, who was not involved in the research.

Potentially, it's "a cost-effective method for reducing mucositis in patients receiving radiation," Dr. Radhakrishnan said.

The next step is a phase III trial, Dr. Mesia said.