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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-28

Study Completion Date

2022-02-03

Brief Summary

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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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Detailed Description

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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.

Conditions

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Malignant Neoplasm Oral Pain Stomatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Given standard of care therapy

Methylene Blue

Intervention Type DRUG

Given lower dose PO

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.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Given standard of care therapy

Methylene Blue

Intervention Type DRUG

Given medium dose PO

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.

Group Type EXPERIMENTAL

Best Practice

Intervention Type OTHER

Given standard of care therapy

Methylene Blue

Intervention Type DRUG

Given higher dose PO

Group 4 (standard of care)

Patients receive standard of care therapy.

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Given standard of care therapy

Interventions

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Best Practice

Given standard of care therapy

Intervention Type OTHER

Methylene Blue

Given lower dose PO

Intervention Type DRUG

Methylene Blue

Given medium dose PO

Intervention Type DRUG

Methylene Blue

Given higher dose PO

Intervention Type DRUG

Other Intervention Names

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standard of care standard therapy 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 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 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

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No