Study of Dentoxol® Mouthrinse for Oral Mucositis

Oral Mucositis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02885376
• Other study ID #: ING-001
• Status: Completed
• Phase: Phase 2
• Start date: November 2014
• Est. completion date: August 2018

Study information

• Verified date: December 2018
• Source: Ingalfarma SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: August 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

Device:
• Dentoxol
Mouthrinse
• Placebo
Mouthrinse

Locations

Country	Name	City	State
Chile	Clinica IRAM	Santiago
Chile	Fundación Arturo López Pérez	Santiago
Chile	Instituto Nacional del Cáncer	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Ingalfarma SpA

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)