Oral pain, odynophagia and dysphagia, weight loss, dehydration, systemic infection, feeding support and hospitalization should be mentioned as the main determinated effect of oral mucositis (OM); this toxicity is often linked to chemo- or chemoradiotherapy. Oral Mucositis can reduce patients’compliance to cancer treatment and decreased their quality of life; it could be also reduce survival caused by discontinuation or dose reduction of anti-neoplasm therapy. The purpose of this study is to evaluate the impact of the three different products on OM outcomes of patients who received radio and chemotherapy in solid cancer.
From March to June 2018, 60 patients (pts) were randomized by Medical Oncology Unit of Rho - Milan. The pts were divided in 3 arms, belanced for tumor site and treatment, to receive the following medical devices: Gelx (oral spray), Episil (oral solution) and Gelclair (oral gel). Primary aim of the study was evaluation of OM onset, severity, reduction or remission and pain relief with the three devices in study. We analysed data with forms compiled by pts in 2 different steps: T0 (baseline) and follow-up (after 16 w); the clinicians evaluated OM grade in 2 steps: after 4 w and after 8 w. The pts’safety profile form included 10 items concerning difficulty of speaking, feeding, drinking and change of taste.
The data analysis showed a significant difference among the 3 Groups. OM grade of Group 2 after 4 weeks is higher if compared with Group 1 and Group 3 After 4 weeks two cases of grade 4 mucositis has been achieved in Group 2, none in Group 1 and Group 3. Group GELX (Zinco gluconate included) demonstrated an overall better efficacy, in every analyzed safety profile items.
Even if prevention and treatment of OM are not yet clearly defined and recognized in the clinical practice, the study shows how the correct use of anti- mucositis product (accompanied by an appropriate hygienic and dietetic regimen) seems to be effective in the prevention of this pathology, which is the most frequent side effects on patients undergoing chemotherapy.
Clinical trial identification
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Has not received any funding.
All authors have declared no conflicts of interest.