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Methylene Blue Mouthwash for Oral Mucositis Pain
Phase 3
Recruiting
Led By Regina M Mackey, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 days
Awards & highlights
Study Summary
This trial compares a new mouthwash to standard of care to treat oral pain from cancer-related mucositis. It may improve oral pain and provide a better treatment.
Who is the study for?
This trial is for cancer patients with severe mouth sores (Grade 3-4 oral mucositis) causing pain, who are currently hospitalized. Participants must have an active cancer diagnosis and be able to give informed consent.Check my eligibility
What is being tested?
The study is testing if methylene blue mouthwash can better manage pain from severe mouth sores in cancer patients compared to the standard care mouthwash typically used for this condition.See study design
What are the potential side effects?
Potential side effects of methylene blue mouthwash may include tooth staining, increased saliva production, a burning sensation or irritation in the mouth, and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in oral pain
Secondary outcome measures
Change in the amount of daily requirements of oral morphine equivalents
Change in the amount of oral intake
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Methylene Blue Mouthwash GroupExperimental Treatment1 Intervention
Patients receive Methylene Blue mouthwash as needed on study.
Group II: Standard of Care Mouthwash GroupActive Control1 Intervention
Patients receive standard of care mouthwash as needed on study.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,209 Previous Clinical Trials
3,767,090 Total Patients Enrolled
Regina M Mackey, M.D.Principal InvestigatorMayo Clinic in Rochester
Regina M MackeyPrincipal InvestigatorMayo Clinic in Rochester
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently diagnosed with cancer.I am currently admitted to a hospital.I have pain due to mouth sores.I am experiencing pain in my throat or mouth.I am under 18 years old.I am not allergic to methylene blue and do not have G6PD deficiency.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Mouthwash Group
- Group 2: Methylene Blue Mouthwash Group
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the regulatory status of GROUP II (Methylene blue mouthwash) according to Food and Drug Administration regulations?
"Our team at Power evaluated the safety of using GROUP II (Methylene blue mouthwash) and gave it a score of 3. This is because there are Phase 3 trial results showing efficacy, as well as numerous studies that back its safety."
Answered by AI
Is there an ongoing recruitment process for this clinical trial?
"According to clinicaltrials.gov, this trial is no longer enrolling patients; it was originally posted on June 3rd 2023 and the last update occurred on May 18th of that same year. However, there are a plethora of other studies seeking volunteers at present with 2626 open trials across the world."
Answered by AI
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