MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)
Malignant Neoplasm, Oral Pain, Stomatitis
About this trial
This is an interventional treatment trial for Malignant Neoplasm
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
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Group 1 (lower dose methylene blue, standard of care)
Group 2 (medium dose methylene blue, standard of care)
Group 3 (higher dose methylene blue, standard of care)
Group 4 (standard of care)
Patients receive lower dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
Patients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
Patients receive higher dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
Patients receive standard of care therapy.