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Study of Dentoxol® Mouthrinse for Oral Mucositis

Primary Purpose

Oral Mucositis

Status

Completed

Phase

Phase 2

Locations

Chile

Study Type

Interventional

Intervention

Dentoxol

Placebo

About this trial

This is an interventional prevention trial for Oral Mucositis focused on measuring Mucositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Clinica IRAM
Fundación Arturo López Pérez
Instituto Nacional del Cáncer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dentoxol

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale

Secondary Outcome Measures

Duration of and time to onset of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale.

Mouth pain scores, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).

Ability to eat, drink, and swallow, as measured in the Oral Mucositis Daily Questionnaire (OMDQ).

Weight loss, as measured by the difference between weight on first and last day of radiation therapy.

Use of opioid analgesics for oral mucositis pain, as expressed in morphine equivalents.

Full Information

NCT ID

NCT02885376

First Posted

August 26, 2016

Last Updated

December 19, 2018

Sponsor

Ingalfarma SpA

1. Study Identification

Unique Protocol Identification Number

NCT02885376

Brief Title

Study of Dentoxol® Mouthrinse for Oral Mucositis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

April 2018 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ingalfarma SpA

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Mucositis

Keywords

Mucositis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

108 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dentoxol

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Dentoxol

Intervention Description

Mouthrinse

Intervention Type

Device

Intervention Name(s)

Placebo

Intervention Description

Mouthrinse

Primary Outcome Measure Information:

Title

Incidence of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale

Time Frame