MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer
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|ClinicalTrials.gov Identifier: NCT03461354|
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : February 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Mucositis Oral Head and Neck Cancer||Drug: MucoLox Drug: Sodium Bicarbonate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||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|
|Actual Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
MucoLox formulation, with MucoLox as the delivery vehicle, combined with preserved water, beta-glucan, dexpanthenol, and glutamine
Active Comparator: B
Sodium Bicarb Control Arm
Drug: Sodium Bicarbonate
Sodium bicarbonate oral rinse
- AUC for the Oral Mucositis Daily Questionnaire mouth and throat soreness question #2 [ Time Frame: 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
- Time to OMDQ MTS > 2 [ Time Frame: One month ]To compare the time to OMDQ MTS Q2 > 2 between the two arms
- Opioid use (morphine equivalent daily dose) [ Time Frame: 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
- Assess remaining OMDQ questions [ Time Frame: One month ]To assess changes in the remaining OMDQ questions longitudinally throughout study treatment and compare between the two arms.
- Duration of symptom relief [ Time Frame: One month ]To evaluate and compare the duration of symptom relief in those who experience any degree of oral mucositis between the two arms
- Frequency of chemoradiation delays [ Time Frame: One month ]To evaluate the frequency of delays in [chemotherapy and/or radiation] therapy throughout the study period and compare between the two arms.
- Oral mucositis grade [ Time Frame: 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.
- Drug-related adverse events [ Time Frame: One month ]To summarize the rates of potential side effects related to each oral formulation, including but not limited to mouth discomfort, allergic reactions, exacerbation of mucositis symptoms, mouth ulcers, dry mouth, unpleasant taste or dysgeusia. Safety variables include AEs and SAEs related to the study treatment. Adverse events will be evaluated continuously throughout the study. Safety, tolerability, relationship to study treatment, and intensity will be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461354
|Contact: Tia Riley||704-403-0501||Tia.Riley@atriumhealth.org|
|United States, North Carolina|
|Levine Cancer Institute||Recruiting|
|Charlotte, North Carolina, United States, 28204|
|Contact: Tia Riley 704-403-0501 Tia.Riley@atriumhealth.org|
|Principal Investigator: Jai N Patel, PharmD, BCOP|
|Principal Investigator:||Jai Patel, PharmD, BCOP||Levine Cancer Institute, Atrium Health (formerly Carolinas HealthCare System)|