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

Primary Purpose

Mucositis, Neoplasms

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Oral Defense Toothpaste
Crest Toothpaste
Magic Mouth Rinse
Sponsored by
Oral Defense, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucositis focused on measuring oral mucositis, chemotherapy, toothpaste

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Summit Cancer Centers

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oral Defense Toothpaste

Crest Toothpaste/Magic Mouth Rinse

Arm Description

The experimental group will brush with Oral Defense Toothpaste three times per day during the study

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 1, 2015
Last Updated
February 4, 2019
Sponsor
Oral Defense, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02606994
Brief Title
Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis
Acronym
TPvsM
Official Title
Comparison of the Healing of Chemotherapy-Induced Oral Mucositis Using Oral Defense Toothpaste Versus Crest Toothpaste and Magic Mouth Rinse
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Lack of enrollment
Study Start Date
May 29, 2018 (Actual)
Primary Completion Date
February 4, 2019 (Actual)
Study Completion Date
February 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oral Defense, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis, Neoplasms
Keywords
oral mucositis, chemotherapy, toothpaste

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Defense Toothpaste
Arm Type
Experimental
Arm Description
The experimental group will brush with Oral Defense Toothpaste three times per day during the study
Arm Title
Crest Toothpaste/Magic Mouth Rinse
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral Defense Toothpaste
Other Intervention Name(s)
Experimental toothpaste
Intervention Description
Brush with a Oral Defense Toothpaste three times per day during the study
Intervention Type
Drug
Intervention Name(s)
Crest Toothpaste
Other Intervention Name(s)
Control Toothpaste
Intervention Description
Brush with Crest Toothpaste three times per day during the study
Intervention Type
Drug
Intervention Name(s)
Magic Mouth Rinse
Other Intervention Name(s)
Viscous Lidocaine 2%, Maalox, Diphenhydramine 12.5mg/5ml
Intervention Description
Participants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse
Primary Outcome Measure Information:
Title
Oral mucositis changes
Description
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 Outcome Measure Information:
Title
Quality of life changes
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arvind Chaudhry, MD,PhD
Organizational Affiliation
Summit Cancer Centers, Seattle Cancer Care Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Summit Cancer Centers
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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