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Effects of Aqualief® in Patients With Xerostomia as Consequence of Radiotherapy for Head and Neck Cancer

NCT03601962 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-01-27

No results posted yet for this study

Summary

The treatment of xerostomia is aimed to increase existing saliva flow or replace lost secretions, the control of the state of oral health, the control of dental caries, and the treatment of possible infections.

Therapy options in xerostomia depend on the presence of residual secretion or the absence of it. When residual secretory capacity is present, it is advisable to regularly stimulate the salivary glands by mechanical or gustatory stimuli as supportive oral care.

Aqualief® is a food supplement based on carnosine and hibiscus. These two ingredients are mixed in specific proportions to form a pH buffering system which maintains the pH of the oral cavity at the proper value which is required for the regular secretion of saliva.

Conditions

  • Xerostomia
  • Asialia
  • Hyposalivation
  • Mouth Dryness

Interventions

DIETARY_SUPPLEMENT

Aqualief

400mg oral mucoadesive tablets

OTHER

Placebo

400mg Placebo oral mucoadesive tablets

Sponsors & Collaborators

  • Latis S.r.l.

    collaborator INDUSTRY

  • Helsinn Healthcare SA

    lead INDUSTRY

Principal Investigators

  • Ester Orlandi, MD · Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-31
Primary Completion
2020-01-22
Completion
2020-01-22

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03601962 on ClinicalTrials.gov