MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

Not Applicable

Active, not recruiting

• Conditions: Head and Neck Cancer; Mucositis Oral
• Interventions: Other: Sodium Bicarbonate; Other: MucoLox

• Registration Number: NCT03461354
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Study Timeline

• Study First Submitted: 2018-02-27
• Study First Submitted QC: 2018-03-08
• Study First Posted: 2018-03-12
• Study Start: 2018-04-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Sodium Bicarbonate	Sodium Bicarb Control Arm
A	MucoLox	Mucolox Arm

Primary Outcome Measures

Name	Time	Method
AUC for the Oral Mucositis Daily Questionnaire mouth and throat soreness question #2	One month	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 Outcome Measures

Name	Time	Method
Comparison of self-reported OMDQ scores versus investigator-assessed mucositis	Weekly during the one month study period	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.
Opioid use (morphine equivalent daily dose)	Weekly during the one-month study period	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
Duration of symptom relief	One month	To evaluate and compare the duration of symptom relief in those who experience any degree of oral mucositis between the two arms
Time to OMDQ MTS > 2	One month	To compare the time to OMDQ MTS Q2 \> 2 between the two arms
Oral mucositis grade	Weekly during the one month study period	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.
Assess remaining OMDQ questions	One month	To assess changes in the remaining OMDQ questions longitudinally throughout study treatment and compare between the two arms.
Frequency of chemoradiation delays	One month	To evaluate the frequency of delays in \[chemotherapy and/or radiation\] therapy throughout the study period and compare between the two arms.

Trial Locations

Locations (1)

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States