Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis
NCT ID: NCT02606994
Last Updated: 2019-02-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
1 participants
INTERVENTIONAL
2018-05-29
2019-02-04
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Oral Defense Toothpaste
The experimental group will brush with Oral Defense Toothpaste three times per day during the study
Oral Defense Toothpaste
Brush with a Oral Defense Toothpaste three times per day during the study
Crest Toothpaste/Magic Mouth Rinse
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.
Crest Toothpaste
Brush with Crest Toothpaste three times per day during the study
Magic Mouth Rinse
Participants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse
Interventions
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Oral Defense Toothpaste
Brush with a Oral Defense Toothpaste three times per day during the study
Crest Toothpaste
Brush with Crest Toothpaste three times per day during the study
Magic Mouth Rinse
Participants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mucositis lesions not exceeding grade 2
Exclusion Criteria
* Patients receiving radiation therapy
* Patients receiving oral antivirals, oral antifungals or oral antibacterials
* Patients experiencing oral candidiasis
18 Years
ALL
No
Sponsors
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Oral Defense, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Arvind Chaudhry, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Summit Cancer Centers, Seattle Cancer Care Alliance
Locations
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Summit Cancer Centers
Spokane, Washington, United States
Countries
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Other Identifiers
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OralDefenseMucositisStudy
Identifier Type: -
Identifier Source: org_study_id
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