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

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Stomatitis; Malignant Neoplasm; Oral Pain

Treatments: Other: Best Practice; Drug: Methylene Blue

Study type: Interventional

Funder types: Other

Identifiers

NCT03469284

NCI-2018-00822 (Registry Identifier)

2016-1051 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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69 participants in 4 patient groups

Group 1 (lower dose methylene blue, standard of care)

Experimental group

Description:

Patients receive lower dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.

Treatment:

Drug: Methylene Blue

Other: Best Practice

Drug: Methylene Blue

Drug: Methylene Blue

Group 2 (medium dose methylene blue, standard of care)

Experimental group

Description:

Patients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.

Treatment:

Drug: Methylene Blue

Other: Best Practice

Drug: Methylene Blue

Drug: Methylene Blue

Group 3 (higher dose methylene blue, standard of care)

Experimental group

Description:

Patients receive higher dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.

Treatment:

Drug: Methylene Blue

Other: Best Practice

Drug: Methylene Blue

Drug: Methylene Blue

Group 4 (standard of care)

Active Comparator group

Description:

Patients receive standard of care therapy.

Treatment:

Other: Best Practice