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

NCT02606994 | Terminated Phase 2

• 1 other identifier: OralDefenseMucositisStudy
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mucositis; Neoplasms

Keywords

oral mucositis; chemotherapy; toothpaste

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of life changes

  8 days

Study Arms (2)

Oral Defense Toothpaste

EXPERIMENTAL

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

Drug: Oral Defense Toothpaste

Crest Toothpaste/Magic Mouth Rinse

PLACEBO COMPARATOR

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; Drug: Magic Mouth Rinse

Interventions

Oral Defense Toothpaste DRUG

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

Also known as: Experimental toothpaste

Oral Defense Toothpaste

Crest Toothpaste DRUG

Brush with Crest Toothpaste three times per day during the study

Also known as: Control Toothpaste

Crest Toothpaste/Magic Mouth Rinse

Magic Mouth Rinse DRUG

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

Also known as: Viscous Lidocaine 2%, Maalox, Diphenhydramine 12.5mg/5ml

Crest Toothpaste/Magic Mouth Rinse

Eligibility Criteria

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

You may qualify if:

• Patients over the age of 18 receiving chemotherapy
• Mucositis lesions not exceeding grade 2

You may not qualify if:

• Patients receiving high load chemotherapy
• Patients receiving radiation therapy
• Patients receiving oral antivirals, oral antifungals or oral antibacterials
• Patients experiencing oral candidiasis

Sponsors & Collaborators

• Oral Defense, LLC: lead

Study Sites (1)

Summit Cancer Centers

Spokane, Washington, 99208, United States

Location

MeSH Terms

Conditions

Mucositis; Neoplasms; Stomatitis

Interventions

hydrated silica gel-based toothpaste; Lidocaine; aluminum hydroxide, magnesium hydroxide, drug combination; Diphenhydramine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethylamines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Arvind Chaudhry, MD,PhD

  Summit Cancer Centers, Seattle Cancer Care Alliance

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2015
• First Posted: November 17, 2015
• Study Start: May 29, 2018
• Primary Completion: February 4, 2019
• Study Completion: February 4, 2019
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)