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

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

doi:10.3390/cancers13143456

Submit to this Journal Review for this Journal Edit a Special Issue

Article Menu

...

Open AccessArticle

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

Nicola Alessandro Iacovelli

^1,*,†

Rossana Ingargiola

^1,†,

Nadia Facchinetti

¹,

Marzia Franceschini

¹,

Domenico Attilio Romanello

¹,

²,

²,

² and

^1,4

Radiation Oncology Unit 2, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133 Milan, Italy

Head and Neck Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Via Venezian 1, 20133 Milan, Italy

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)

View Full-Text Download PDF

Browse Figures

Citation Export

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, Aqualief^TM, in patients treated with curative radiotherapy for HNC. The results show that Aqualief^TM 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 Aqualief^TM may become a promising tool for the treatment of radiotherapy-related xerostomia. In addition, the results also suggest that Aqualief^TM may have positive effects in the maintenance of oral health.

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, Aqualief^TM, in patients treated with curative RT with or without chemotherapy for HNC. Aqualief^TM 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, Aqualief^TM 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 Aqualief^TM 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. Aqualief^TM 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: Aqualief^TM; xerostomia; radiotherapy; head and neck cancer; carnosine; karkadé

▼ Show Figures

Figure 1

This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited

Share and Cite

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 Aqualief^TM 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 Aqualief^TM 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 Aqualief^TM Mucoadhesive Tablets in Head and Neck Cancer Patients Who Developed Radiation-Induced Xerostomia" Cancers 13, no. 14: 3456. https://doi.org/10.3390/cancers13143456

Find Other Styles

Note that from the first issue of 2016, MDPI journals use article numbers instead of page numbers. See further details here.

Article Metrics

Abstract views Pdf views Html views

Article Menu

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

Simple Summary

Abstract

Share and Cite

Article Metrics

Article Access Statistics

Article Access Map by Country/Region

Further Information

Guidelines

MDPI Initiatives

Follow MDPI