MucositisPhase 2TPvsMNCT02606994
Effect of Over-the-counter Toothpastes on Chemotherapy-induced Oral Mucositis
A Phase 2 study testing Oral Defense Toothpaste, Crest Toothpaste and Magic Mouth Rinse in people with Mucositis and Neoplasms, run by Oral Defense, LLC at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Oral Defense Toothpaste causes accelerated healing of chemotherapy-induced oral mucositis. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Oral Defense Toothpaste, Crest Toothpaste and Magic Mouth Rinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2018to 4 Feb 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 receiving chemotherapy
- Mucositis lesions not exceeding grade 2
Who cannot join
- Patients receiving high load chemotherapy
- Patients receiving radiation therapy
- Patients receiving oral antivirals, oral antifungals or oral antibacterials
- Patients experiencing oral candidiasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Healing of Chemotherapy-Induced Oral Mucositis Using Oral Defense Toothpaste Versus Crest Toothpaste and Magic Mouth Rinse
The purpose of this study is to determine whether Oral Defense Toothpaste causes accelerated healing of chemotherapy-induced oral mucositis.
Read the 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.
- Being tested
- Oral Defense Toothpaste, Crest Toothpaste, Magic Mouth Rinse
- Keywords
- oral mucositis, chemotherapy, toothpaste
- Medical subject headings
- Mucositis, Neoplasms, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Defense ToothpasteDrug
Also called Experimental toothpaste
Brush with a Oral Defense Toothpaste three times per day during the study
Crest ToothpasteDrug
Also called Control Toothpaste
Brush with Crest Toothpaste three times per day during the study
Magic Mouth RinseDrug
Also called Viscous Lidocaine 2%, Maalox, Diphenhydramine 12.5mg/5ml
Participants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse
| Study group | Role | What they receive |
|---|---|---|
| Oral Defense Toothpaste | Experimental | The experimental group will brush with Oral Defense Toothpaste three times per day during the study Receives: 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. Receives: Drug: Crest Toothpaste; Drug: Magic Mouth Rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 and 8 of the study
Secondary outcomes (1)
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.
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study start29 May 2018
- Primary completion4 Feb 2019
- Study completion4 Feb 2019
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oral Defense, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arvind Chaudhry, MD,PhD, Principal investigator, Summit Cancer Centers, Seattle Cancer Care Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606994
- Sponsor's protocol ID
- OralDefenseMucositisStudy
- Acronym
- TPvsM
- Status last verified
- Feb 2019
- First submitted
- 1 Nov 2015
- Last updated
- 6 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Healing of Chemotherapy-Induced Oral Mucositis Using Oral Defense Toothpaste Versus Crest Toothpaste and Magic Mouth Rinse
- ClinicalTrials.gov ID
- NCT02606994
- Acronym / sponsor ID
- TPvsM / OralDefenseMucositisStudy
- Keywords
- oral mucositis, chemotherapy, toothpaste
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Oral Defense, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 May 2018 (actual)
- Primary completion
- 4 Feb 2019 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Defense Toothpaste | Experimental | Drug: Oral Defense ToothpasteThe experimental group will brush with Oral Defense Toothpaste three times per day during the study |
| Crest Toothpaste/Magic Mouth Rinse | Placebo comparator | Drug: Crest Toothpaste, Drug: Magic Mouth RinseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients over the age of 18 receiving chemotherapy
- Mucositis lesions not exceeding grade 2
Key exclusion criteria (4 listed)
- Patients receiving high load chemotherapy
- Patients receiving radiation therapy
- Patients receiving oral antivirals, oral antifungals or oral antibacterials
- Patients experiencing oral candidiasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Defense ToothpasteAlso: Experimental toothpasteBrush with a Oral Defense Toothpaste three times per day during the study | Drug | Oral Defense Toothpaste |
| Crest ToothpasteAlso: Control ToothpasteBrush with Crest Toothpaste three times per day during the study | Drug | Crest Toothpaste/Magic Mouth Rinse |
| Magic Mouth RinseAlso: Viscous Lidocaine 2%, Maalox, Diphenhydramine 12.5mg/5mlParticipants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse | Drug | Crest Toothpaste/Magic Mouth Rinse |
Primary outcome
Oral mucositis changes
Time frame: Day 1 and 8 of the study
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.
1 secondary outcome
Quality of life changes
Time frame: 8 days
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arvind Chaudhry, MD,PhD principal investigator
Summit Cancer Centers, Seattle Cancer Care Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral Defense Toothpaste, Crest Toothpaste and Magic Mouth Rinse in people with Mucositis and Neoplasms, run by Oral Defense, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral mucositis changes (time frame: Day 1 and 8 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2019.