Clinical trial · Interventional
MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)
Randomized Controlled Trial Comparing 4 Intervention Arms, Including 3 Different Concentrations of Methylene Blue Oral Rinse Combined With Conventional Therapy and Conventional Therapy, in Patients With Intractable Pain Associated With Oral Mucositis
NCT03469284CI-TRIAL-00065921completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial studies how well methylene blue works in treating patients with cancer and pain associated with oral mucositis. Methylene blue may relieve pain associated with oral mucositis.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Oral Pain | — | UNRESOLVED | — |
| Stomatitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Methylene Blue | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Group 1 (lower dose methylene blue, standard of care)
- description
- Patients receive lower dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
- interventionNames
- Other: Best Practice
- Drug: Methylene Blue
- type
- EXPERIMENTAL
- label
- Group 2 (medium dose methylene blue, standard of care)
- description
- Patients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
- interventionNames
- Other: Best Practice
- Drug: Methylene Blue
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a cancer diagnosis, receiving chemotherapy, radiation therapy or the combination * Patients with a current diagnosis of oral mucositis * Patients with pain and oral dysfunction associated with oral mucositis despite conventional therapy * Voluntary written consent * Patient must agree to use of contraception or abstinence from sex during the treatment period and for 30 days after patient's last dose Exclusion Criteria: * Patients with known allergy to MB * Patients taking medications with known significant drug interactions * Pregnant or lactating patients * Patients who are cognitively impaired and unable to consent for the study * Patients with risk of broncho-aspiration based on documented swallowing test by a speech pathologist (if available) * Patients with known history of G6PD deficiency * Patients undergoing any other experimental intervention for oral mucositis * Patients who have no pain or impairment in oral function, patients who are not symptomatic * Patients with head and neck cancer * Patients on serotonergic drugs
References
Publications (1)
- DERIVEDRoldan CJ, Huh B, Song J, Nieto Y, Osei J, Chai T, Nouri K, Koyyalagunta L, Bruera E. Methylene blue for intractable pain from oral mucositis related to cancer treatment: a randomized phase 2 clinical trial. BMC Med. 2022 Nov 3;20(1):377. doi: 10.1186/s12916-022-02579-8. PMID 36324139