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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03469284.
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of methylene blue (MB) in reducing the severity of mucositis-related pain, measured by numeric rating scale (NRS), in cancer patients who underwent or are undergoing chemotherapy or radiation therapy.
OUTLINE: Patients are randomized to 1 of 4 groups.
GROUP 1: Patients receive lower dose methylene blue orally (PO) to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
GROUP 2: Patients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
GROUP 3: Patients receive higher dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
GROUP 4: Patients receive standard of care therapy. Patients may cross-over and be randomized to Groups 1-3 after the first 2 checkups.
After completion of study treatment, patients are followed up at 1, 2, 7, and 30 days.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorCarlos Roldan
