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

49 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will examine if the administration of prophylactic MucoLox formulation versus sodium bicarbonate mouthwash in subjects with head/neck cancer receiving radiation ± chemotherapy will result in significantly fewer subjects experiencing severe mucositis.

Research Team

Jai Patel, PharmD, BCOP

Principal Investigator

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

Eligibility Criteria

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

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

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

Able and willing to provide informed consent

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

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

Treatment Details

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.

Participant Groups

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+