MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)

• Status: Active, not recruiting
• Trial end date: 2022-02-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Methylene Blue

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