Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis

Phase 2TerminatedNCT02606994

Oral Defense, LLC1 enrolled

Overview

The purpose of this study is to determine whether Oral Defense Toothpaste causes accelerated healing of chemotherapy-induced oral mucositis.

A pilot study showed that patients with chemotherapy-induced oral mucositis experienced accelerated healing of their oral mucositis by brushing with Oral Defense Toothpaste. In this study, participants experiencing up to grade 2 chemotherapy-induced oral mucositis will be split into two arms. The first arm (test arm) will receive Oral Defense Toothpaste and be required to brush three times per day, for 8 days. The second arm (control arm) will receive Crest Toothpaste and be required to brush three times per day, for 8 days. Patients in the control arm will be provided Magic Mouth Rinse, if needed. Healing of oral mucositis lesions will be evaluated at days 1 and 8. Quality of life assessment (determination of pain/loss of oral function) will be determined using a daily questionnaire.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Mucositis Neoplasms

Interventions

Oral Defense ToothpasteDRUG

Brush with a Oral Defense Toothpaste three times per day during the study

Crest ToothpasteDRUG

Brush with Crest Toothpaste three times per day during the study

Magic Mouth RinseDRUG

Participants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients over the age of 18 receiving chemotherapy * Mucositis lesions not exceeding grade 2 Exclusion Criteria: * Patients receiving high load chemotherapy * Patients receiving radiation therapy * Patients receiving oral antivirals, oral antifungals or oral antibacterials * Patients experiencing oral candidiasis

Locations (1)

Summit Cancer Centers

Spokane, Washington, United States

Outcomes

Primary Outcomes

Oral mucositis changes

The primary measure is the healing of chemotherapy induced oral mucositis lesions which are evaluated at days 1 and 8 of the study. The clinical investigators will identify patients who qualify for the study and this will mark day 1 of the study. At days 1 and 8 of the study, the clinical investigators will evaluate the oral cavity of each study participant and document changes in the oral mucositis of the participants.

Time frame: Day 1 and 8 of the study

Secondary Outcomes

Quality of life changes

Each participant will fill out a quality of life questionnaire every day of the study. An evaluated outcome is when their chemotherapy induced oral mucositis lesions have resolved and their quality of life has returned to pre-chemotherapy levels.

Time frame: 8 days

Data from ClinicalTrials.gov

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