What side effects are associated with this type of intervention?

Common treatments for blood cancers, such as chemotherapy and radiation therapy, often lead to side effects including oral mucositis, which is painful inflammation and ulceration of the mucous membranes lining the mouth. Other side effects include nausea, vomiting, fatigue, hair loss, and increased risk of infections. Chemotherapy can also cause taste changes, dry mouth, and increased susceptibility to oral infections. Radiation therapy may lead to similar oral complications, along with potential damage to salivary glands, leading to chronic dry mouth and dental issues.

What prior FDA approvals exist?

FDA-approved treatments for blood cancers include a variety of chemotherapeutic agents, targeted therapies, and immunotherapies. For example, venetoclax is approved for chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML), while ivosidenib is approved for AML with specific genetic mutations. These treatments focus on targeting cancer cells directly rather than providing antiseptic or analgesic properties. Methylene blue mouthwash, being studied for its antiseptic and analgesic properties in oral mucositis, represents a different therapeutic approach aimed at symptom management rather than directly treating the cancer itself.

What other types of research exist?

Promising alternatives to Methylene Blue Mouthwash for treating oral mucositis pain in blood cancer patients include: 1) Topical treatments containing amitriptyline and ketamine, which have shown improvement in neuropathic pain symptoms. 2) L-glutamine supplementation, which has demonstrated benefits in reducing sensory neuropathy. 3) Daylight photodynamic therapy with methyl aminolevulinate cream, which is effective and nearly painless for treating actinic keratosis and may have potential applications in mucositis.

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Methylene Blue Mouthwash for Oral Mucositis Pain

Phase 3

Recruiting

Led By Regina M Mackey, M.D.

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 days

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing whether a special mouthwash called methylene blue can better relieve mouth pain in cancer patients with oral mucositis compared to the usual mouthwash. Oral mucositis is a common and painful side effect of cancer treatments. Anecdotal experience has suggested that methylene blue (MB) oral rinse may be an effective and safe treatment of oral pain due to mucositis in patients with cancer.

Who is the study for?

This trial is for cancer patients with severe mouth sores (Grade 3-4 oral mucositis) causing pain, who are currently hospitalized. Participants must have an active cancer diagnosis and be able to give informed consent.

What is being tested?

The study is testing if methylene blue mouthwash can better manage pain from severe mouth sores in cancer patients compared to the standard care mouthwash typically used for this condition.

What are the potential side effects?

Potential side effects of methylene blue mouthwash may include tooth staining, increased saliva production, a burning sensation or irritation in the mouth, and possible allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 3 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in oral pain

Secondary study objectives

Change in the amount of daily requirements of oral morphine equivalents

Change in the amount of oral intake

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Methylene Blue Mouthwash GroupExperimental Treatment1 Intervention

Patients receive Methylene Blue mouthwash as needed on study.

Group II: Standard of Care Mouthwash GroupActive Control1 Intervention

Patients receive standard of care mouthwash as needed on study.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for blood cancers include chemotherapy, radiation therapy, and supportive treatments like methylene blue mouthwash. Chemotherapy works by targeting rapidly dividing cancer cells, disrupting their growth and replication. Radiation therapy uses high-energy radiation to damage the DNA of cancer cells, leading to cell death. Methylene blue mouthwash, studied for its antiseptic and analgesic properties, helps manage oral mucositis pain, a common side effect of cancer treatments. These treatments are crucial for blood cancer patients as they directly target cancer cells and alleviate treatment-related complications, improving overall patient outcomes and quality of life.

Effect of two oral care protocols on the incidence of stomatitis in hematology patients.Oral cancer and mouthwash use: evaluation of the epidemiologic evidence.Indications for and referrals to oral care for cancer patients in a county hospital.