Phase 2
N=60
MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)
Malignant Neoplasm · Oral Pain · Stomatitis
Bottom Line
View on ClinicalTrials.gov: NCT03469284 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcome: Primary: Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool — 1.69; 5.2; 4.54; 5.15 score on a scale — p=0.0034
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Best Practice (Other); Methylene Blue (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool |
1.69; 5.2; 4.54; 5.15 | 0.0034 sig |
| SECONDARY Change in Oral Function Burden (OFB) Scores |
0.81; 2.47; 2.79; 2.87 | 0.0008 sig |
| SECONDARY World Health Organization Oral Mucositis Severity Grades |
1; 0; 1; 4; 15; 15 | — |
| SECONDARY Morphine Equivalent Daily Doses (MEDD) |
117.5; 115; 107; 120 | 0.9182 |
| SECONDARY Pain Duration |
5.5; 8; 6; 5 | 0.1046 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03469284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.