| Title: |
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Study to Evaluate the Efficacy of Aqualief TM Mucoadhesive Tablets in Head and Neck Cancer Patients Who Developed Radiation-Induced Xerostomia. |
| Authors: |
Iacovelli, Nicola Alessandro, Ingargiola, Rossana, Facchinetti, Nadia, Franceschini, Marzia, Romanello, Domenico Attilio, Bossi, Paolo, Bergamini, Cristiana, Alfieri, Salvatore, Cavalieri, Stefano, Baron, Giovanna, Aldini, Giancarlo, Locati, Laura, Orlandi, Ester |
| Source: |
Cancers; Jul2021, Vol. 13 Issue 14, p3456, 1p |
| Subject Terms: |
THERAPEUTIC use of plant extracts, DRUG efficacy, DRUG tablets, HEAD tumors, HYDROGEN-ion concentration, NEUROPEPTIDES, DIETARY supplements, RANDOMIZED controlled trials, PLACEBOS, CANCER patients, COMPARATIVE studies, XEROSTOMIA, BLIND experiment, SALIVATION, DESCRIPTIVE statistics, RADIATION injuries, RADIOTHERAPY, PLANT extracts, CROSSOVER trials, NECK tumors, LONGITUDINAL method, EVALUATION |
| Abstract: |
Simple Summary: Xerostomia, the subjective complaint of dry mouth, is caused by therapeutic interventions or diseases. Nowadays, radiotherapy 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 clinical study with a new product, AqualiefTM, in patients treated with curative radiotherapy for HNC. The results show that AqualiefTM stimulated salivation in these patients and reduced the pH drop that was observed in an equivalent population of patients treated with placebo. Moreover, no serious, treatment-related adverse events were observed. These encouraging results suggest that AqualiefTM may become a promising tool for the treatment of radiotherapy-related xerostomia. In addition, the results also suggest that AqualiefTM may have positive effects in the maintenance of oral health. 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. [ABSTRACT FROM AUTHOR] |
|
Copyright of Cancers is the property of MDPI and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| Database: |
Complementary Index |
