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

Primary Purpose

Malignant Neoplasm, Oral Pain, Stomatitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Methylene Blue
Methylene Blue
Methylene Blue
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

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)

Arm Description

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

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

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

Patients receive standard of care therapy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Oral Function Burden (OFB) Scores
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.
World Health Organization Oral Mucositis Severity Grades
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 Soreness/erythema Soreness/erythema + ulceration + ability to eat solid foods 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).
Morphine Equivalent Daily Doses (MEDD)
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.
Pain Duration
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.

Full Information

First Posted
March 13, 2018
Last Updated
April 20, 2023
Sponsor
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03469284
Brief Title
MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2019 (Actual)
Primary Completion Date
February 3, 2022 (Actual)
Study Completion Date
February 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm, Oral Pain, Stomatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (lower dose methylene blue, standard of care)
Arm Type
Experimental
Arm Description
Patients receive lower dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
Arm Title
Group 2 (medium dose methylene blue, standard of care)
Arm Type
Experimental
Arm Description
Patients receive medium dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
Arm Title
Group 3 (higher dose methylene blue, standard of care)
Arm Type
Experimental
Arm Description
Patients receive higher dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.
Arm Title
Group 4 (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care therapy.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Given standard of care therapy
Intervention Type
Drug
Intervention Name(s)
Methylene Blue
Other Intervention Name(s)
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
Intervention Description
Given lower dose PO
Intervention Type
Drug
Intervention Name(s)
Methylene Blue
Other Intervention Name(s)
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
Intervention Description
Given medium dose PO
Intervention Type
Drug
Intervention Name(s)
Methylene Blue
Other Intervention Name(s)
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
Intervention Description
Given higher dose PO
Primary Outcome Measure Information:
Title
Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool
Description
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.
Time Frame
Baseline up to day 7
Secondary Outcome Measure Information:
Title
Change in Oral Function Burden (OFB) Scores
Description
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.
Time Frame
Baseline up to day 7
Title
World Health Organization Oral Mucositis Severity Grades
Description
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 Soreness/erythema Soreness/erythema + ulceration + ability to eat solid foods 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).
Time Frame
Up to day 2
Title
Morphine Equivalent Daily Doses (MEDD)
Description
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.
Time Frame
Baseline to Day 2
Title
Pain Duration
Description
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.
Time Frame
Up to 30-90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Roldan
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36324139
Citation
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.
Results Reference
derived
Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

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

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