MucoLox for Mucositis in Head/Neck Cancer

Overseen By Tia Riley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Magic mouthwash, Amifostine

Disqualifiers: Oral infections, Immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a new treatment, MucoLox, can reduce severe mouth sores in individuals with head or neck cancer undergoing radiation, with or without chemotherapy. It compares MucoLox to a standard sodium bicarbonate mouthwash to determine which is more effective. Candidates for this trial include those with confirmed head or neck cancer who are scheduled for radiation therapy affecting the mouth or throat area. As an unphased trial, this study provides a unique opportunity to contribute to research that may enhance comfort and quality of life for future patients.

Do I have to stop taking my current medications for the trial?

You can continue taking your current medications, but you must not use any other mouthwash formulations to prevent or treat oral mucositis during the study. Analgesics, antibiotics, antifungals, and hydration for symptom management are allowed.

What prior data suggests that MucoLox is safe for use in head/neck cancer patients?

Research has shown that MucoLox is a safe option for treating mouth conditions like oral mucositis. In studies, MucoLox was used without major safety concerns for managing oral diseases. This treatment is a gel that adheres to the inside of the mouth and alleviates symptoms like painful mouth sores. Reports suggest that people tolerated MucoLox well, with few side effects noted. Overall, the safety of MucoLox appears promising for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

MucoLox is unique because it offers a new approach to reducing mucositis in head and neck cancer patients. Unlike traditional treatments that often include mouthwashes or pain management strategies like sodium bicarbonate rinses, MucoLox is designed to form a protective coating over the mucosal surfaces, potentially reducing irritation and pain more effectively. Researchers are excited about MucoLox because it targets the physical aspect of mucositis by acting as a barrier, which could lead to improved patient comfort and faster recovery times.

What evidence suggests that MucoLox might be an effective treatment for mucositis?

Research shows that painful mouth sores, known as oral mucositis, commonly affect patients with head and neck cancer undergoing radiation or chemotherapy. Studies indicate that about 65-70% of these patients experience severe oral mucositis. This trial tests MucoLox in one treatment arm to determine if it can reduce these painful sores. MucoLox might work by creating a protective layer in the mouth, potentially lessening the severity of the sores. Although limited data exists on MucoLox itself, it is designed to alleviate the significant discomfort caused by cancer treatments. Another arm of the trial uses Sodium Bicarbonate as a control to compare its effectiveness against MucoLox. ^{5 6 7 8 9}

Who Is on the Research Team?

Jai Patel, PharmD, BCOP

Principal Investigator

Levine Cancer Institute, Atrium Health (formerly Carolinas HealthCare System)

Are You a Good Fit for This Trial?

Adults with head/neck cancer scheduled for radiation (possibly with chemotherapy) who can perform mouthwash routines and complete questionnaires. They must have a performance status allowing daily activities and be able to consent. Excluded are those on chronic immunosuppression, using other mucositis treatments, or having active oral infections.

Inclusion Criteria

I can swish and spit medicine as my doctor thinks is okay.

Able and willing to complete OMDQ as determined by the treating Investigator

I am mostly able to care for myself and carry out daily activities.

Exclusion Criteria

I haven't taken any drugs for mouth sores in the last week, except for certain allowed ones.

I do not have any mouth, throat, or dental issues that could affect the study.

Use, or suspicion of use, of illicit drugs or substances

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either MucoLox formulation or sodium bicarbonate rinse for the prevention of severe mucositis during radiation ± chemotherapy

4 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Crossover Extension

Participants on the control arm experiencing severe mucositis may crossover to the MucoLox arm for additional treatment

7 ± 2 days or until day 29 ± 5 days, whichever is longer

What Are the Treatments Tested in This Trial?

Interventions

• MucoLox
• Sodium Bicarbonate

Trial Overview The trial is testing whether MucoLox, a new mouthwash formulation, is more effective than sodium bicarbonate in preventing severe mucositis in patients undergoing radiation therapy for head/neck cancer.

How Is the Trial Designed?

Group I: A Experimental Treatment 1 Intervention

Mucolox Arm

Group II: B Active Control 1 Intervention

Sodium Bicarb Control Arm

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Atrium Health

Lead Sponsor

Trials

122

Recruited

34,900+

Atrium Health Levine Cancer Institute

Collaborator

Trials

30

Recruited

4,700+

Professional Compounding Centers of America

Industry Sponsor

Trials

1

Recruited

50+

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2810484

Severe Oral Mucositis After IMRT for Head and Neck Cancer The sequelae of OM have been shown to increase opioid use, weight loss, feeding tube placement, and hospitalization among patients with HNC.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1053429625000165

Oral Mucositis in Head and Neck Cancer Patients Severe oral mucositis (SOM), defined as WHO grade 3 and grade 4, occurs in 65-70% of patients receiving concurrent cisplatin and radiation therapy for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8184418/

Narrative review of the management of oral mucositis ... Abstract. Oral mucositis (OM) can be a significant problem for patients undergoing radiation or chemoradiation for head and neck cancer.

4. nature.com nature.com/articles/s41368-025-00382-8

Expert consensus on the prevention and treatment of ... For example, more than 90% of patients treated with systemic RT experience OM, and at least 33% of patients undergoing local RT for head and ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11987221/

Impact of an oral care intervention protocol on oral health ... These data suggest that the OCIP is clinically helpful in maintaining overall oral health among cancer patients receiving head and neck radiation/ ...

6. pccarx.com pccarx.com/pdf_files/98929_TR_MucoLox_HumOralMuc_1-3.pdf

Evaluation of the Safety and Toxicological Profile of MucoLox MucoLox may then be used in pharmaceutical compounding as a safe option in the treatment of diseases and conditions of the oral mucosa such as oral mucositis,.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK565848/

Oral Mucositis - StatPearls - NCBI Bookshelf Oral mucositis is a severely debilitating condition characterized by erythema, edema, and ulcerations of the oral mucosa.

8. clin.larvol.com clin.larvol.com/trial-detail/NCT03461354

MucoLox Formulation to Mitigate Mucositis Symptoms in ... Safety, tolerability, relationship to study treatment, and intensity will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) ...

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/jop.13471

Dexamethasone solution and dexamethasone in Mucolox ... Mucolox™ is a mucoadhesive polymer gel used in pharmaceutical compounding for the management of oral diseases, including oral mucositis and ...