Symptoms and General Pathology

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Pain

Stomatitis

Mucositis

Pain, Intractable

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

All Drugs and Chemicals

Methylene Blue

Enzyme Inhibitors

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.

Best Practice

Carlos Roldan

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.

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.

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

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

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.

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.

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).

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.

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.

M.D. Anderson Cancer Center

Participants receive standard of care therapy.

Conventional Therapy (Controlled Arm)

Participants receive 0.025% dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.

Conventional Therapy + Methylene Blue (MB) 0.025%

Participants receive 0.05% dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.

Conventional Therapy + Methylene Blue (MB) 0.05%

Participants receive 0.1% dose methylene blue PO to swish and spit for 5 minutes every 6 hours then receive standard of care therapy.

Spots Global Cancer Trial Database for MOM's PAIN (Methylene Blue for Oral Mucositis' PAIN)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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