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

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

Detailed Description
-----------------
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.

Official Title
-----------------
Comparison of the Healing of Chemotherapy-Induced Oral Mucositis Using Oral Defense Toothpaste Versus Crest Toothpaste and Magic Mouth Rinse

Conditions
-----------------
Mucositis, Neoplasms

Intervention / Treatment
-----------------
* Drug: Oral Defense Toothpaste
* Drug: Crest Toothpaste
* Drug: Magic Mouth Rinse


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Defense Toothpaste<br>The experimental group will brush with Oral Defense Toothpaste three times per day during the study | Drug: Oral Defense Toothpaste<br>* Brush with a Oral Defense Toothpaste three times per day during the study<br>* Other names: Experimental toothpaste;|
| Placebo Comparator: Crest Toothpaste/Magic Mouth Rinse<br>The placebo group will brush with Crest Toothpaste three times per day during the study. Participants in the placebo comparator group who require additional management of their oral mucositis pain will be provided Magic Mouth Rinse. | Drug: Crest Toothpaste<br>* Brush with Crest Toothpaste three times per day during the study<br>* Other names: Control Toothpaste;Drug: Magic Mouth Rinse<br>* Participants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse<br>* Other names: Viscous Lidocaine 2%, Maalox, Diphenhydramine 12.5mg/5ml;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 1 and 8 of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral mucositis, chemotherapy, toothpaste