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

April 20, 2023 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1 (lower dose methylene blue, standard of care)
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
Given standard of care therapy
Other Names:
  • standard of care
  • standard therapy
Drug: Methylene Blue
Given lower dose PO
Other Names:
  • Urolene Blue
  • 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
  • Vitableu
Drug: Methylene Blue
Given medium dose PO
Other Names:
  • Urolene Blue
  • 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
  • Vitableu
Drug: Methylene Blue
Given higher dose PO
Other Names:
  • Urolene Blue
  • 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
  • Vitableu
Experimental: Group 2 (medium dose methylene blue, standard of care)
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
Given standard of care therapy
Other Names:
  • standard of care
  • standard therapy
Drug: Methylene Blue
Given lower dose PO
Other Names:
  • Urolene Blue
  • 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
  • Vitableu
Drug: Methylene Blue
Given medium dose PO
Other Names:
  • Urolene Blue
  • 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
  • Vitableu
Drug: Methylene Blue
Given higher dose PO
Other Names:
  • Urolene Blue
  • 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
  • Vitableu
Experimental: Group 3 (higher dose methylene blue, standard of care)
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
Given standard of care therapy
Other Names:
  • standard of care
  • standard therapy
Drug: Methylene Blue
Given lower dose PO
Other Names:
  • Urolene Blue
  • 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
  • Vitableu
Drug: Methylene Blue
Given medium dose PO
Other Names:
  • Urolene Blue
  • 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
  • Vitableu
Drug: Methylene Blue
Given higher dose PO
Other Names:
  • Urolene Blue
  • 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
  • Vitableu
Active Comparator: Group 4 (standard of care)
Patients receive standard of care therapy.
Other: Best Practice
Given standard of care therapy
Other Names:
  • standard of care
  • standard therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool
Time Frame: Baseline up to day 7
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Oral Function Burden (OFB) Scores
Time Frame: Baseline up to day 7
Oral functioning (eat, swallow, talk: unable=2, difficulty=1, able=0. Oral functioning score is the total score of 3 categories, ranged 0-6). Scale is included in the Modified Harris mucositis-related pain assessment tool. Measurements are obtained at day 0, 1, 2, and 7. Modified Harris mucositis-related pain assessment tool. Lowest value=0 representing normal. Highest value =6 representing worst outcome.
Baseline up to day 7
World Health Organization Oral Mucositis Severity Grades
Time Frame: Up to day 2

Used the WHO grading system (0= no mucositis, 3=severe mucositis) The clinical severity of the OM was documented only at enrollment point to the study. Most of the patients had the grade 3 mucositis (Soreness/erythema + ulceration + ability to use a liquid diet only), per World Health Organization criteria. See table below which indicates the description of the various grades.

Grade Description 0 No changes

  1. Soreness/erythema
  2. Soreness/erythema + ulceration + ability to eat solid foods
  3. Soreness/erythema + ulceration + ability to use a liquid diet only

Secondary endpoint included oral functioning burden (0=normal, 6= worse oral function) (OFB; measured on a scale of 0, representing normal, to 6, meaning total inability, reflecting a total score of three categories: the ability to eat, swallow, and talk, each scored as unable = 2, difficult = 1, able = 0).
Up to day 2
Morphine Equivalent Daily Doses (MEDD)
Time Frame: Baseline to Day 2

Morphine equivalent daily dose (MEDD) used for oral mucositis pain at 2 post MB administration.

Before the study was implemented, it was observed that many patients had pain resolved just within a few doses. Therefore, the study aimed to cover only 100 cc of MB, which typically last about 2 days. Some patients requested more MB after the two days which had to be provided by the pharmacy and ordered by the primary team and paid by patient insurance. This was considered out of the study, but the patients were still followed. Also, there was no average, only self-reported level of pain from the patient at point of data collection.
Baseline to Day 2
Pain Duration
Time Frame: Up to 30-90 days
Measured the days the patient was in pain. The study aimed to cover only 100 cc of MB, which typically last about 2 days. Some patients requested more MB after the two days which had to be provided by the pharmacy and ordered by the primary team and paid by patient insurance. This was considered out of the study, but the patients were still followed. We followed for 30-90 days (no treatment for 30-90 days), only to observe for AEs. Also, there was no average, only self-reported level of pain from the patient at point of data collection.
Up to 30-90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
M.D. Anderson Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Carlos Roldan, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 3, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-1051 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2018-00822 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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