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Study of Dentoxol® Mouthrinse for Oral Mucositis

NCT ID: NCT02885376

Last Updated: 2018-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Oral Mucositis

Keywords

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Mucositis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Dentoxol

Intervention Type DEVICE

Mouthrinse

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Mouthrinse

Interventions

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Dentoxol

Mouthrinse

Intervention Type DEVICE

Placebo

Mouthrinse

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ingalfarma SpA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastián Sole

Role: PRINCIPAL_INVESTIGATOR

Clinica IRAM

Locations

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Clinica IRAM

Santiago, , Chile

Site Status

Fundación Arturo López Pérez

Santiago, , Chile

Site Status

Instituto Nacional del Cáncer

Santiago, , Chile

Site Status

Countries

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Chile

Other Identifiers

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ING-001

Identifier Type: -

Identifier Source: org_study_id