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COMPLETEDPhase 2NCT02885376

Study of Dentoxol® Mouthrinse for Oral Mucositis

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.

Lead sponsor: Ingalfarma SpA•3 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Ingalfarma SpA

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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)

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 21, 2018Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2

Enrollment108

Start dateNov 2014

Last updatedDec 21, 2018

Condition

Locations shown

Clinica IRAM

Santiago

Fundación Arturo López Pérez

Santiago

Instituto Nacional del Cáncer

Santiago

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 21, 2018Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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