A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate the Efficacy of AqualiefTM Mucoadhesive Tablets in Head and Neck Cancer Patients Who Developed Radiation-Induced Xerostomia

Abstract

Xerostomia, the subjective complaint of dry mouth, is caused by therapeutic interventions or diseases. Nowadays, radiotherapy (RT) in patients with head and neck cancer (HNC) stands out as one of the most important causes of xerostomia. Currently available therapies for the treatment of xerostomia are still less than optimal and xerostomia still represents an unmet clinical need. In this article, we present the results of a prospective clinical study with a new product, AqualiefTM, in patients treated with curative RT with or without chemotherapy for HNC. AqualiefTM is based on two main ingredients, carnosine and karkadé, which have acid buffering and antioxidant properties. The study was performed on 30 patients, with 4 of the patients being lost during the study period. Each patient received randomly one of the two treatments, AqualiefTM or placebo, for 8 days. After a 10-day wash-out period, each patient received the other treatment for a further 8 days. The results show that AqualiefTM stimulated salivation in these patients and reduced the pH drop that was observed in an equivalent placebo-treated population of patients. Moreover, no serious, treatment-related adverse events were observed. AqualiefTM has shown positive results, although with limitations due to unsuccessful trial accrual. Therefore, it may be further investigated as a tool for the treatment of RT-related xerostomia.

Localized Drug Delivery Systems: An Update on Treatment Options for Head and Neck Squamous Cell Carcinomas

“…Clinical trials with mucoadhesive dietary supplements, were initiated for the treatment of radiation-induced xerostomia but had to be terminated due to low recruitment [ 151 ]. However, recent studies did show that the dietary supplement, Aqualief, was able to restore salivary secretion with reduced adverse effects; however, further studies are required due to the unsuccessful accrual of subjects [ 152 ]. Newer therapeutic methods for delivering Xylitol, another common salivary stimulant, are also being considered.…”

Radiation-Induced Xerostomia in Patients with Head and Neck Cancer Treated with Comprehensive Salivary Gland-Sparing Helical Tomotherapy Technique: Based on a Backpropagation Artificial Neural Network

“…Models for predicting radiation-induced xerostomia, founded on the Normal Tissue Complication Probability (NTCP) concept, have been widely explored utilizing 2D or 3D irradiation techniques [8] . These studies have employed univariate or multiple logistic regression models to examine the interplay between dose-target volume and the likelihood of side effects [9] . Nonetheless, in clinical practice, clinical indicators, in addition to radiation dose and target volume, signi cantly contribute to xerostomia risk [10] .…”