Hematopoietic and Lymphoid System NeoplasmPhase 3NCT05878405
Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer
A Phase 3 study testing Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse and Methylene Blue Oral Rinse in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm, Stomatitis
- What is being tested?
- Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse and Methylene Blue Oral Rinse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2023to 6 Dec 2024
- Phase
- Phase 3
- 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
- Active cancer diagnosis
- Admitted to the inpatient setting
- Pain related to oral mucositis
- Experiencing oropharyngeal pain
- Able to provide informed consent
Who cannot join
- Pediatric age (under 18 years old)
- Pregnant or nursing women
- Any contraindication to methylene blue including severe hypersensitivity to methylene blue and patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer: An Open-Label, Non-Randomized, Controlled Study
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.
- Being tested
- Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse, Methylene Blue Oral Rinse
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth RinseOther
Also called Dentoxol, Dentoxol Mouthrinse
Given PO
Methylene Blue Oral RinseOther
Also called MB Oral Rinse
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care Mouthwash Group | Active comparator | Patients receive standard of care mouthwash as needed on study. Receives: Other: Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse |
| Methylene Blue Mouthwash Group | Experimental | Patients receive Methylene Blue mouthwash as needed on study. Receives: Other: Methylene Blue Oral Rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oral pain
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.
Measured: Baseline, 3 days
Secondary outcomes (2)
Change in the amount of oral intake
Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output
Measured: Baseline, 3 days
Change in the amount of daily requirements of oral morphine equivalents
Electronic medical records will be reviewed for demographic and clinical information, medication administration record, and intake and output
Measured: Baseline, 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start6 Jun 2023
- Primary completion6 Dec 2024
- Study completion6 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Regina M Mackey, M.D., Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878405
- Sponsor's protocol ID
- 22-007588
- Other IDs
- NCI-2023-03542, 22-007588
- Status last verified
- Apr 2025
- First submitted
- 10 May 2023
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer: An Open-Label, Non-Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05878405
- Acronym / sponsor ID
- 22-007588
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Jun 2023 (actual)
- Primary completion
- 6 Dec 2024 (actual)
- Study completion
- 6 Dec 2024 (actual)
- First posted
- 26 May 2023 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care Mouthwash Group | Active comparator | Other: Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth RinsePatients receive standard of care mouthwash as needed on study. |
| Methylene Blue Mouthwash Group | Experimental | Other: Methylene Blue Oral RinsePatients receive Methylene Blue mouthwash as needed on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Active cancer diagnosis
- Admitted to the inpatient setting
- Pain related to oral mucositis
- Experiencing oropharyngeal pain
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Pediatric age (under 18 years old)
- Pregnant or nursing women
- Any contraindication to methylene blue including severe hypersensitivity to methylene blue and patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia
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 |
|---|---|---|
| Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth RinseAlso: Dentoxol, Dentoxol MouthrinseGiven PO | Other | Standard of Care Mouthwash Group |
| Methylene Blue Oral RinseAlso: MB Oral RinseGiven PO | Other | Methylene Blue Mouthwash Group |
Primary outcome
Change in oral pain
Time frame: Baseline, 3 days
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.
2 secondary outcomes
Change in the amount of oral intake
Time frame: Baseline, 3 days
Change in the amount of daily requirements of oral morphine equivalents
Time frame: Baseline, 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Regina M Mackey, M.D. principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anti-inflammatory/Antimicrobial/Analgesic Aqueous Mouth Rinse and Methylene Blue Oral Rinse in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 30 Apr 2025. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in oral pain (time frame: Baseline, 3 days). 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 30 Apr 2025.