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

Malignant Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469284
• Other study ID #: 2016-1051
• Secondary ID: NCI-2018-0082220
• Status: Completed
• Phase: Phase 2
• Start date: February 28, 2019
• Est. completion date: February 3, 2022

Study information

• Verified date: April 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: February 3, 2022
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Mucositis
• Neoplasms
• Oral Pain
• Stomatitis

Intervention

Other:
• Best Practice
Given standard of care therapy

Drug:
• Methylene Blue
Given lower dose PO
• Methylene Blue
Given medium dose PO
• Methylene Blue
Given higher dose PO

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline up to day 7
Secondary	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.	Baseline up to day 7
Secondary	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).	Up to day 2
Secondary	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.	Baseline to Day 2
Secondary	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.	Up to 30-90 days

External Links

•   MD Anderson Cancer Center