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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
49
MucoLox formulation, with MucoLox as the delivery vehicle, combined with preserved water, beta-glucan, dexpanthenol, and glutamine
Sodium bicarbonate oral rinse
Levine Cancer Institute
Charlotte, North Carolina, United States
AUC for the Oral Mucositis Daily Questionnaire mouth and throat soreness question #2
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
Time frame: One month
Time to OMDQ MTS > 2
To compare the time to OMDQ MTS Q2 \> 2 between the two arms
Time frame: One month
Opioid use (morphine equivalent daily dose)
To estimate opioid use defined as the average morphine equivalent daily dose (MEDD) at each clinic visit: baseline, day 8 ± 2, day 15 ± 2, day 22 ± 2, and the final study visit (day 29 ± 5) and compare between the two arms
Time frame: Weekly during the one-month study period
Assess remaining OMDQ questions
To assess changes in the remaining OMDQ questions longitudinally throughout study treatment and compare between the two arms.
Time frame: One month
Duration of symptom relief
To evaluate and compare the duration of symptom relief in those who experience any degree of oral mucositis between the two arms
Time frame: One month
Frequency of chemoradiation delays
To evaluate the frequency of delays in \[chemotherapy and/or radiation\] therapy throughout the study period and compare between the two arms.
Time frame: One month
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Oral mucositis grade
To summarize the prevalence and grade of oral mucositis at each clinic visit: baseline, day 8 ± 2, day 15 ± 2, day 22 ± 2, and the final study visit (day 29 ± 5), as assessed by the treating investigator using the WHO criteria for grading, and compare between the two arms.
Time frame: Weekly during the one month study period
Comparison of self-reported OMDQ scores versus investigator-assessed mucositis
The Generalized McNemar's test will be used to analyze correlation between patient report OMDQ Q2 scores and oral mucositis grading assessed by treating investigator using WHO criteria.
Time frame: Weekly during the one month study period