Study of Dentoxol® Mouthrinse for Oral Mucositis

December 19, 2018 updated by: Ingalfarma SpA

Phase II Study of Dentoxol® Mouthrinse for Oral Mucositis Secondary to Radiation Therapy for Head and Neck Cancer

The primary objective of this study is to determine the efficacy of Dentoxol® mouthrinse in reducing the severity of oral mucositis secondary to radiation therapy for head and neck cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Fundacion Arturo Lopez Perez
      • Santiago, Chile
        • Instituto Nacional del Cancer
      • Santiago, Chile
        • Clinica IRAM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Planned to receive radiation therapy for cancer of the oral cavity, oropharynx, nasopharynx, hypopharynx or larynx, with or without concomitant chemotherapy.
  • Planned to receive at least 5000cGy radiation therapy to at least 2 of 12 pre-specified areas in the oral cavity

Exclusion Criteria:

  • Unable to give written informed consent
  • Known allergy/intolerance to any component of the study rinse or placebo
  • Planning to use any contraindicated medications during the study period (pain medications are allowed)
  • Age below 18 years
  • Pregnant or nursing (If the patient is a woman of childbearing potential, a pregnancy test must be performed within fourteen days before enrollment in the study)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dentoxol
Dentoxol® is a proprietary mouthrinse that has anti-inflammatory, antimicrobial and analgesic effects. Subjects will use Dentoxol® mouthrinse 5 times each day, starting on the first day of radiation therapy and ending on the last day of radiation therapy.
Device: Dentoxol
Mouthrinse
Placebo Comparator: Placebo
The placebo rinse will be identical in color, taste and consistency as the Dentoxol rinse and will be packaged in identical bottles with the same labels. Subjects will use placebo mouthrinse 5 times each day, starting on the first day of radiation therapy and ending on the last day of radiation therapy.
Device: Placebo
Mouthrinse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale
Time Frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
First day of radiation therapy through last day of radiation therapy (5-8 weeks)

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of and time to onset of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale.
Time Frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Mouth pain scores, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).
Time Frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Ability to eat, drink, and swallow, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).
Time Frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Weight loss, as measured by the difference between weight on first and last day of radiation therapy.
Time Frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
First day of radiation therapy through last day of radiation therapy (5-8 weeks)
Use of opioid analgesics for oral mucositis pain, as expressed in morphine equivalents.
Time Frame: First day of radiation therapy through last day of radiation therapy (5-8 weeks)
First day of radiation therapy through last day of radiation therapy (5-8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ingalfarma SpA

Investigators

  • Principal Investigator: Sebastián Sole, Clinica IRAM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (Estimate)

August 31, 2016

Study Record Updates

Last Update Posted (Actual)

December 21, 2018

Last Update Submitted That Met QC Criteria

December 19, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ING-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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