Efficacy of a Dietary Supplement (Aqualief®) in Xerostomic Patients

NCT ID: NCT03612414

Last Updated: 2018-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-15
• Study Completion Date: 2017-12-15

Brief Summary

Xerostomia is defined as the subjective complaint of dry mouth. Symptoms of dry mouth may range from mild oral discomfort to significant oral disease that can compromise patients' health, dietary intake and quality of life. Xerostomia is accompanied by numerous signs and symptoms mainly in the mucous membranes, lips, tongue, salivary glands and teeth.

This study was designed to verify efficacy and safety of a novel dietary supplement (Aqualief),designed with the aim of stabilizing the saliva flux and pH at a neutral level and to improve the acid buffering capacity of saliva.

Detailed Description

Sixty patients with xerostomia (grade 1-2 according to RTOG/EORTC) from different etiologies were recruited at the Clinica Odontoiatrica dell'Università degli studi dell'Insubria (Varese, Italy). Exclusion criteria were subjects under treatment using drugs to treat hyposalivation (e.g. pilocarpine) and xerostomia grade ≥ 3. Patients with severe hyposalivation were excluded (saliva flow rate at baseline <0.1 ml min-1) due to their inability to dissolve the tablet formulation.

Written informed consent was received from all patients before study initiation. The study was conducted in accordance with the principles laid out by the Declaration of Helsinki 1964 and its subsequent amendments and with the International Committee on Harmonization Guidelines for Good Clinical Practice and in compliance with local ethical and legal requirements. The study was approved by the ethics committee at the participating site.

The study was a prospective, randomized, double-blind, placebo-controlled trial undertaken at the Clinica Odontoiatrica dell'Università degli Studi dell'Insubria (Varese, Italy). Eligible patients who had developed xerostomia RTOG/EORTC grade 1-2 were randomized in a 1:1 ratio, with one group receiving three Aqualief tablets (after meals: breakfast, lunch, dinner) daily for 6 days. The second group received a placebo tablet given with the same regimen. The primary objective of the study was to assess the safety and efficacy of Aqualief in stabilizing the saliva pH at a neutral level compared with placebo. The secondary objective was to determine whether Aqualief induced an increase of unstimulated or stimulated saliva and in ameliorating the symptoms related to oral dryness.

Conditions

Xerostomia Due to Hyposecretion of Salivary Gland; pH; Saliva; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Aqualief® tablets

400 mg mucoadhesive tablets; three times per day just

Group Type: EXPERIMENTAL

Aqualief

Intervention Type: DIETARY_SUPPLEMENT

Three tablets/day

Placebo tablets

400 mg mucoadhesive placebo tablets, three times per day just

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Three tablets/day

Interventions

Aqualief

Three tablets/day

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Three tablets/day

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Subjects of both sex
• Age ≥ a 18 years
• Able to understand and sign the Informed Consent, and fill in the patient's diary
• Subjects suffering from Xerosotmia Grade 1-2 (according to RTOG/EORTC scale)
• Sjögren Sindrome
• Lambert-Eaton Sindrome
• Diabetes mellitus and low metabolic control
• Anxiety
• Alcool abuse
• Salivary glands trauma
• Radio and Chemotherapy for head & neck cancer
• Methamphetamine, cannabis, heroin abuse
• Xerostomia caused by (single and concomitant, i.e. Anti-depressive and anxyolitic drugs; Antihistaminic drugs; Decongestive drugs; Antihypertensive drugs; Muscle relaxants; Urinary incontinence drugs; Drugs for Parkinson treatment)
• Subjects affected by paradental pathology diagnosed according to AAOP criteria, PSR 2-3

Exclusion Criteria

• Contraindication and/or Hypersensitivity to product's components, and in particular carnosine and Hibiscus
• Subjects that are under treatment with products or drugs ( ie pilocarpin) for hypofunctionality of salivary glands
• Subjects with total ablation of salivary glands caused by chemo or radiotherapy
• Use of experimental drugs during 30 days before the enrolment or during the study
• Conditions that can interfere with the study
• Xerostomia grade 3 or higher

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi dell'Insubria

OTHER

Sponsor Role: lead

Responsible Party

Prof. Luca Levrini

Director of the Department of Surgery and Medicine, Dental Hygiene School, Research Centre Cranio Facial Disease and Medicine, University of Insubria, Varese Italy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Levrini, Prfo. MD.

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi dell'Insubria

Locations

Università degli Studi dell'Insubria

Varese, , Italy

Countries

Italy

Other Identifiers

Prot.49 May 31st, 2016

Identifier Type: -

Identifier Source: org_study_id