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NCT05878405 · ClinicalTrials.gov registry record · Phase 3
Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer
A Phase 3 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 3
- Development phase
- 49
- Enrollment target
NCT05878405: Completed Phase 3 study, sponsored by Mayo Clinic.
NCT05878405 is a Phase 3 study that has completed, run by Mayo Clinic. The registered enrollment target is 49 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05878405, a Phase 3 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 49 participants
- Enrollment target
Study Summary
This phase III trial compares the effect of methylene blue mouthwash to standard of care mouthwash for the treatment of oral mucositis pain in patients with cancer. Using methlylene blue mouthwash may improve oral pain in patients with oral mucositis related to cancer and/or cancer treatments compared to usual standard of care.
Primary Outcome
Pain will be assessed using the standard institutional numeric rating scale where pain level is quantified on a scale of 0 (no pain) to 10 (worst possible pain) pre- and post-intervention (3 times daily for 3 days). Last collected scores will be compared to baseline.
Interventions
- OTHER Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse
- OTHER Methylene Blue Oral Rinse
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2023-06-06 |
| Est. Completion | 2024-12-06 |
| Phase | Phase 3 |
What the finished NCT05878405 record still lists
NCT05878405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse is the first listed.
NCT05878405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05878405 about?
NCT05878405 is a clinical study titled "Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer". This phase III trial compares the effect of methylene blue mouthwash to standard of care mouthwash for the treatment of oral mucositis pain in patients with cancer. Using methlylene blue mouthwash may improve oral pain in patients with oral mucositis related to cancer and/or cancer treatments compar...
What is the current status of trial NCT05878405?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 49 participants. The study started on 2023-06-06. Estimated completion is 2024-12-06.
What interventions are being tested in trial NCT05878405?
The interventions under investigation include: Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse (OTHER), Methylene Blue Oral Rinse (OTHER).
Who is sponsoring clinical trial NCT05878405?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05878405's enrollment target sits among peer trials
49 1860th of 2000 higher than 139 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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