NCT03461354

MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

Phase II Randomized Trial of an Oral Formulation Containing a Mucoadhesive Polymer Hydrogel Vehicle (MucoLox®) to Mitigate Mucositis Symptoms in Head/Neck Cancer Patients Receiving Radiation ± Chemotherapy

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The primary objective of this double-arm, single-blinded, Phase II randomized study is to compare the area under the curve (AUC) for the Oral Mucositis Daily Questionnaire (OMDQ) mouth and throat soreness (MTS) question 2 (Q2) score over a one-month period in subjects receiving the MucoLox formulation versus sodium bicarbonate rinse (as the control) for the prevention of severe mucositis in subjects with head/neck cancer receiving radiation ± chemotherapy. Secondary objectives include comparing the time to OMDQ MTS Q2 \> 2 between the two arms; estimating and comparing opioid use defined as the average morphine equivalent daily dose (MEDD) at each clinic visit; assessing and comparing changes in the remaining OMDQ questions longitudinally throughout study; evaluating and comparing the duration of symptom relief in those who experience any degree of oral mucositis; evaluating and comparing the frequency of delays in \[chemotherapy and/or radiation\] therapy throughout the study period; and summarizing and comparing the prevalence and grade of oral mucositis at each clinic visit. The safety objective is to summarize the rates of potential side effects related to each oral formulation. A total of 60 eligible subjects will be enrolled and randomized in a 1:1 fashion to one of the treatment arms. Subjects on the control arm (sodium bicarbonate) who experience severe mucositis will have the option to crossover to the Mucolox arm for an additional 7 ± 2 days or until day 29 ± 5 days, whichever is longer.

Conditions

• Mucositis Oral
• Head and Neck Cancer

Interventions

Type	Name	Description
OTHER	MucoLox	MucoLox formulation, with MucoLox as the delivery vehicle, combined with preserved water, beta-glucan, dexpanthenol, and glutamine
OTHER	Sodium Bicarbonate	Sodium bicarbonate oral rinse

Timeline

• Start date: 2018-04-09
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2018-03-12
• Last updated: 2025-02-06

Locations

1 site across 1 country: United States