Study of Dentoxol® Mouthrinse for Oral Mucositis

Phase 2

Completed

• Conditions: Oral Mucositis

• Registration Number: NCT02885376
• Lead Sponsor: Ingalfarma SpA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-08-31
• Primary Completion: 2018-04
• Study Completion: 2018-08
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-19
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Duration of and time to onset of severe oral mucositis, defined as grade 3 or 4 on the World Health Organization (WHO) scale.	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).	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).	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.	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.	First day of radiation therapy through last day of radiation therapy (5-8 weeks)

Trial Locations

Locations (3)

Clinica IRAM; 🇨🇱 Santiago, Chile

Fundación Arturo López Pérez; 🇨🇱 Santiago, Chile

Instituto Nacional del Cáncer; 🇨🇱 Santiago, Chile