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Article

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

1
Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133 Milan, Italy
2
Head and Neck Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133 Milan, Italy
3
Department of Pharmaceutical Sciences (DISFARM), Università degli Studi di Milano, Via Mangiagalli 25, 20133 Milan, Italy
4
Radiation Oncology Unit 1, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133 Milan, Italy
*
Author to whom correspondence should be addressed.
Authors contributed equally.
Academic Editor: Mari Lloyd-Williams
Cancers 2021, 13(14), 3456; https://doi.org/10.3390/cancers13143456
Received: 24 May 2021 / Revised: 3 July 2021 / Accepted: 8 July 2021 / Published: 10 July 2021
(This article belongs to the Special Issue Supportive and Palliative Care in Oncology)
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. View Full-Text
Keywords: AqualiefTM; xerostomia; radiotherapy; head and neck cancer; carnosine; karkadé AqualiefTM; xerostomia; radiotherapy; head and neck cancer; carnosine; karkadé
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MDPI and ACS Style

Iacovelli, N.A.; Ingargiola, R.; Facchinetti, N.; Franceschini, M.; Romanello, D.A.; Bossi, P.; Bergamini, C.; Alfieri, S.; Cavalieri, S.; Baron, G.; Aldini, G.; Locati, L.; Orlandi, E. 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. Cancers 2021, 13, 3456. https://doi.org/10.3390/cancers13143456

AMA Style

Iacovelli NA, Ingargiola R, Facchinetti N, Franceschini M, Romanello DA, Bossi P, Bergamini C, Alfieri S, Cavalieri S, Baron G, Aldini G, Locati L, Orlandi E. 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. Cancers. 2021; 13(14):3456. https://doi.org/10.3390/cancers13143456

Chicago/Turabian Style

Iacovelli, Nicola A., Rossana Ingargiola, Nadia Facchinetti, Marzia Franceschini, Domenico A. Romanello, Paolo Bossi, Cristiana Bergamini, Salvatore Alfieri, Stefano Cavalieri, Giovanna Baron, Giancarlo Aldini, Laura Locati, and Ester Orlandi. 2021. "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" Cancers 13, no. 14: 3456. https://doi.org/10.3390/cancers13143456

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