Study of Dentoxol® Mouthrinse for Oral Mucositis

NCT02885376 | Completed Phase 2 DMC

• 1 other identifier: ING-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 3

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.

Conditions

Oral Mucositis

Keywords

Mucositis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Study Arms (2)

Dentoxol

EXPERIMENTAL

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.

Device: Dentoxol

Placebo

PLACEBO COMPARATOR

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.

Device: Placebo

Interventions

Dentoxol DEVICE

Mouthrinse

Dentoxol

Placebo DEVICE

Mouthrinse

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ingalfarma SpA: lead

Study Sites (3)

Clinica IRAM

Santiago, Chile

Location

Fundación Arturo López Pérez

Santiago, Chile

Location

Instituto Nacional del Cáncer

Santiago, Chile

Location

MeSH Terms

Conditions

Stomatitis; Mucositis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Sebastián Sole

  Clinica IRAM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: August 31, 2016
• Study Start: November 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: August 1, 2018
• Last Updated: December 21, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (3)