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

Sponsor

Università degli Studi dell'Insubria (Other)

Overall Status

Completed

CT.gov ID

NCT03612414

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Xerostomia Due to Hyposecretion of Salivary Gland pH Saliva Quality of Life	Dietary Supplement: Aqualief Dietary Supplement: Placebo	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized, double-blind, placebo-controlled clinical studyrandomized, double-blind, placebo-controlled clinical study

Masking:

Triple (Participant, Care Provider, Investigator)

Masking Description:

Randomization code

Primary Purpose:

Supportive Care

Official Title:

Effetti Sulla Salivazione a Seguito Della Somministrazione di un Integratore Alimentare (Aqualief®) a Base di Carnosina ed Hibiscus Nei Soggetti Xerostomici: Studio Multicentrico, Randomizzato, in Doppio Cieco, Controllato Verso Placebo

Actual Study Start Date :

Jun 15, 2016

Actual Primary Completion Date :

Oct 31, 2017

Actual Study Completion Date :

Dec 15, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aqualief® tablets 400 mg mucoadhesive tablets; three times per day just	Dietary Supplement: Aqualief Three tablets/day
Placebo Comparator: Placebo tablets 400 mg mucoadhesive placebo tablets, three times per day just	Dietary Supplement: Placebo Three tablets/day

Arm

Intervention/Treatment

Experimental: Aqualief® tablets

400 mg mucoadhesive tablets; three times per day just

Dietary Supplement: Aqualief

Three tablets/day

Placebo Comparator: Placebo tablets

400 mg mucoadhesive placebo tablets, three times per day just

Dietary Supplement: Placebo

Three tablets/day

Outcome Measures

Primary Outcome Measures

Effect of Aqualief on salivation [Change from baseline to 6 days of treatment]
Changes in saliva production is measured (ml)

Secondary Outcome Measures

Safety of Aqualief [Occurrence of Adverse Events over the 6 days of treatment]
Incidence of Treatment-Emergent Adverse Events
Effect of Aqualief on dry mouth symptoms [Change from baseline to 6 days of treatment]
Evaluate the effect of treatments dry mouth symptoms trough Dry Mouth Questionnaire (Thomson Questionnaire)
Effect of Aqualief on the pH of saliva [Change from baseline to 6 days of treatment]
Changes of saliva pH is measured

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Università degli Studi dell'Insubria	Varese		Italy	21100

Sponsors and Collaborators

Università degli Studi dell'Insubria

Investigators

Principal Investigator: Luca Levrini, Prfo. MD., Università degli Studi dell'Insubria

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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, Università degli Studi dell'Insubria

ClinicalTrials.gov Identifier:

NCT03612414

Other Study ID Numbers:

Prot.49 May 31st, 2016

First Posted:

Aug 2, 2018

Last Update Posted:

Aug 2, 2018

Last Verified:

Jul 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by 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, Università degli Studi dell'Insubria

Additional relevant MeSH terms:

Xerostomia

Study Results

No Results Posted as of Aug 2, 2018