Methylene Blue in Treating Patients with Cancer and Pain Associated with Oral Mucositis
- 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
- 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
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.
Trial Phase Phase II
Trial Type Treatment
M D Anderson Cancer Center
- Primary ID 2016-1051
- Secondary IDs NCI-2018-00822
- Clinicaltrials.gov ID NCT03469284