Clinical trial

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

Name

2016-1051

Description

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.

Trial arms

Trial start

2019-02-28

Estimated PCD

2022-02-03

Trial end

2022-02-03

Status

Completed

Phase

Early phase I

Treatment

Best Practice

Given standard of care therapy

Arms:

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)

Other names:

standard of care, standard therapy

Methylene Blue

Given lower dose PO

Arms:

Group 1 (lower dose methylene blue, standard of care)

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

Methylene Blue

Given medium dose PO

Arms:

Group 2 (medium dose methylene blue, standard of care)

Other names:

Methylene Blue

Given higher dose PO

Arms:

Group 3 (higher dose methylene blue, standard of care)

Other names:

Size

Primary endpoint

Change in Pain Scores Assessed Within the Numeric Rating Scale (NRS) Component of the Modified Harris Mucositis-related Pain Assessment Tool

Baseline up to day 7

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 69, 'type': 'ACTUAL'}}

Updated at

2023-04-25

1 organization

1 product

3 indications

Organization

M.D. Anderson Cancer Center

Product

Indication

Indication

Indication