Study of Dentoxol® Mouthrinse for Oral Mucositis

Ingalfarma

Status and phase: Completed; Phase 2

Conditions: Oral Mucositis

Treatments: Device: Dentoxol; Device: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02885376

ING-001

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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108 participants in 2 patient groups, including a placebo group

Dentoxol

Experimental group

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.

Treatment:

Device: Dentoxol

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo