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

NCT03469284 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2016-1051NCI-2018-00822
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Neoplasm; Oral Pain; Stomatitis

Outcome Measures

Primary Outcomes (1)

• Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool

  Oral mucositis pain reduction (measured by using the Numeric Rating Scale (NRS); from 0, representing no pain, to 10, representing the worst possible pain) from baseline to 7 days post treatment. The pain scale is included in the Modified Harris mucositis-related pain assessment tool.

  Baseline up to day 7

Secondary Outcomes (4)

• Change in Oral Function Burden (OFB) Scores

  Baseline up to day 7

• World Health Organization Oral Mucositis Severity Grades

  Up to day 2

• Morphine Equivalent Daily Doses (MEDD)

  Baseline to Day 2

• Pain Duration

  Up to 30-90 days

Study Arms (4)

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

EXPERIMENTAL

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

Other: Best Practice; Drug: Methylene Blue

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

EXPERIMENTAL

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

Other: Best Practice; Drug: Methylene Blue

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

EXPERIMENTAL

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

Other: Best Practice; Drug: Methylene Blue

Group 4 (standard of care)

ACTIVE COMPARATOR

Patients receive standard of care therapy.

Other: Best Practice

Interventions

Best Practice OTHER

Given standard of care therapy

Also known as: standard of care, standard therapy

Group 1 (lower dose methylene blue, standard of care); Group 2 (medium dose methylene blue, standard of care); Group 3 (higher dose methylene blue, standard of care); Group 4 (standard of care)

Methylene Blue DRUG

Given lower dose PO

Also known as: Azul de Metileno, Azul Metile, Blu di Metilene, CI Basic Blue 9, CI-52015, Collubleu, Colour Index No. 52015, Desmoidpillen, Methylenum Caeruleum, Methylthioninii Chloridum, Methylthioninium Chloride, Schultz No. 1038, Tetramethylthionine Chloride Trihydrate, Urolene Blue, Vitableu

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Roldan CJ, Huh B, Song J, Nieto Y, Osei J, Chai T, Nouri K, Koyyalagunta L, Bruera E. Methylene blue for intractable pain from oral mucositis related to cancer treatment: a randomized phase 2 clinical trial. BMC Med. 2022 Nov 3;20(1):377. doi: 10.1186/s12916-022-02579-8.

  PMID: 36324139 DERIVED

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Neoplasms; Stomatitis

Interventions

Practice Guidelines as Topic; Standard of Care; Methylene Blue

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Carlos Roldan, Associate Professor, Pain Medicine
• Organization: UT MD Anderson Cancer Center

croldan@mdanderson.org

(713) 563-7402

Study Officials

• Carlos Roldan

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 19, 2018
• Study Start: February 28, 2019
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: April 25, 2023
• Results First Posted: April 21, 2023

Record last verified: 2023-04

Locations

US (1)