NCT03469284

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: 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. After completion of study treatment, patients are followed up at 1, 2, 7, and 30 days.

Conditions

• Malignant Neoplasm
• Oral Pain
• Stomatitis

Interventions

Type	Name	Description
OTHER	Best Practice	Given standard of care therapy
DRUG	Methylene Blue	Given lower dose PO
DRUG	Methylene Blue	Given medium dose PO
DRUG	Methylene Blue	Given higher dose PO

Timeline

• Start date: 2019-02-28
• Primary completion: 2022-02-03
• Completion: 2022-02-03
• First posted: 2018-03-19
• Last updated: 2023-04-25
• Results posted: 2023-04-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study