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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
69
Phase
- 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
-
-
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
Ages Eligible for Study
16 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 |
Intervention / Treatment |
|---|---|
|
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.
|
Given standard of care therapy
Other Names:
Given lower dose PO
Other Names:
Given medium dose PO
Other Names:
Given higher dose PO
Other Names:
|
|
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.
|
Given standard of care therapy
Other Names:
Given lower dose PO
Other Names:
Given medium dose PO
Other Names:
Given higher dose PO
Other Names:
|
|
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.
|
Given standard of care therapy
Other Names:
Given lower dose PO
Other Names:
Given medium dose PO
Other Names:
Given higher dose PO
Other Names:
|
|
Active Comparator: Group 4 (standard of care)
Patients receive standard of care therapy.
|
Given standard of care therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
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
Investigators
- 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.
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)
February 28, 2019
Primary Completion (Actual)
February 3, 2022
Study Completion (Actual)
February 3, 2022
Study Registration Dates
First Submitted
March 13, 2018
First Submitted That Met QC Criteria
March 13, 2018
First Posted (Actual)
March 19, 2018
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 20, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Stomatitis
-
Cairo UniversityUnknown
-
Jagiellonian UniversityUnknownDenture StomatitisPoland
-
Qazvin University Of Medical SciencesCompletedDenture StomatitisIran, Islamic Republic of
-
Badr UniversityNot yet recruiting
-
Cairo UniversityUnknown
-
Mashhad University of Medical SciencesCompletedRecurrent Aphthous StomatitisIran, Islamic Republic of
-
Université de MontréalUniversity of Sao PauloCompleted
-
Université de MontréalMcGill UniversityCompleted
-
Yonsei UniversityCompletedRecurrent Aphthous Stomatitis
Clinical Trials on Best Practice
-
Emory UniversityNational Cancer Institute (NCI); National Center for Complementary and Integrative...RecruitingLymphoma | Multiple MyelomaUnited States
-
University of California, San FranciscoCompleted
-
Sunnybrook Health Sciences CentreCanadian Institutes of Health Research (CIHR); Institute for Clinical Evaluative... and other collaboratorsCompletedHypertension | Diabetes | Ischemic Heart DiseaseCanada
-
University of Massachusetts, WorcesterUniversity of FloridaEnrolling by invitationAtrial FibrillationUnited States
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Not yet recruitingHypertension | Primary Aldosteronism | Hyperaldosteronism | Resistant Hypertension | Mineralocorticoid Excess | Secondary HypertensionUnited States
-
University of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingDiabetes Mellitus, Type 2United States
-
Marmara UniversityUnknown
-
Fred Hutchinson Cancer CenterAmerican College of GastroenterologyRecruitingColorectal CarcinomaUnited States
-
Adient MedicalICON plc; AvaniaActive, not recruitingPulmonary EmbolismUnited States
-
Brigham and Women's HospitalEsperion Therapeutics, Inc.RecruitingPeripheral Vascular Diseases | Dyslipidemias | Peripheral Artery DiseaseUnited States