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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Defense Toothpaste | Experimental | The experimental group will brush with Oral Defense Toothpaste three times per day during the study |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Defense Toothpaste | Drug | Brush with a Oral Defense Toothpaste three times per day during the study |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arvind Chaudhry, MD,PhD | Summit Cancer Centers, Seattle Cancer Care Alliance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Summit Cancer Centers | Spokane | Washington | 99208 | United States |
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| ID | Term |
|---|---|
| D052016 | Mucositis |
| D009369 | Neoplasms |
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| C546060 | hydrated silica gel-based toothpaste |
| D008012 | Lidocaine |
| C013591 | aluminum hydroxide, magnesium hydroxide, drug combination |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Crest Toothpaste | Drug | Brush with Crest Toothpaste three times per day during the study |
|
|
| Magic Mouth Rinse | Drug | Participants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse |
|
|
| D009057 |
| Stomatognathic Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |