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NCT Number: NCT03469284

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

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.

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Key information

Conditions

Malignant Neoplasm Mouth Diseases Neoplasms Oral Pain Stomatitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Given standard of care therapy

Other names: standard of care, standard therapy

Methylene Blue

Drug

Given lower dose PO

Other names: 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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

    • 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).

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2018
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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