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MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

Primary Purpose

Mucositis Oral, Head and Neck Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MucoLox
Sodium Bicarbonate
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mucositis Oral

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Subjects must meet all of the following criteria:

  1. Confirmed head/neck cancer scheduled to receive at least a 28-day course of radiation to the head/neck area (radiation field must include at least one mucosal site within the oral cavity space, oropharynx, hypopharynx or larynx). Subjects must be planned to receive a minimum cumulative dose of 40 Gy and maximum dose of 72 Gy of radiation. Subjects may or may not be scheduled to receive concomitant platinum-based chemotherapy administered with radiation
  2. At least 18 years of age
  3. ECOG performance status less than or equal to 2 or Karnofsky performance score greater than or equal to 70%.
  4. Able and willing to complete OMDQ as determined by the treating Investigator
  5. Able and willing to swish/spit the oral formulation as determined by the treating Investigator
  6. Able and willing to provide informed consent

Exclusion Criteria

Subjects must not meet any of the following criteria:

  1. Receiving any other pharmacological treatment within 1 week of initiation of study treatment for oral mucositis, excluding analgesics, antibiotics, antifungals, and hydration for symptom management. Subjects must also agree to not use any other mouthwash formulations to prevent or treat mucositis during the course of the study.

    1. The subject's enrolling investigator must agree to not prescribe any other mouthwash formulations to prevent or treat oral mucositis during protocol-directed treatment (Note: subjects may receive standard of care treatment if the subject develops oral mucositis and discontinues study treatment [or may crossover to Arm A if randomized to Arm B]).
    2. Subjects must also agree to not use any other mouthwash formulations to prevent or treat oral mucositis during protocol-defined treatment.

    i. Agents suggested to modify oral mucositis risk or course that are not allowed include sodium bicarbonate, magic mouthwash formulations, amifostine, benzydamine, cevimeline, glutamine rinse, topical GM-CSF, interleukin-11, chlorhexidine, hydrogen peroxide, diphenhydramine, palifermin, pilocarpine, steroid rinses, sucralfate, and various oral rinse medical devices

  2. Untreated or unresolved oral infections, including oral candidiasis or active lesions due to oral herpes simplex virus infection that in the opinion of the investigator would compromise study outcomes.
  3. Signs and symptoms of any mouth and/or throat condition or active dental disease that would impair the ability to administer the mouthwash and/or assess the development of oral mucositis, as determined by the Investigator.
  4. Presence of baseline grade > 1 oral mucositis per WHO criteria as determined by the treating investigator
  5. Receiving chronic immunosuppression as determined by the Investigator
  6. Known hypersensitivity to any ingredients in the mouthwash formulations that may result in anaphylaxis.
  7. Use, or suspicion of use, of illicit drugs or substances (self-reported) that may, in the opinion of the Investigator, have a reasonable chance of contributing to non-compliance, opioid abuse, drug toxicity, and/or otherwise skewing the trial result

Sites / Locations

  • Levine Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Mucolox Arm

Sodium Bicarb Control Arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to OMDQ MTS > 2
To compare the time to OMDQ MTS Q2 > 2 between the two arms
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
Assess remaining OMDQ questions
To assess changes in the remaining OMDQ questions longitudinally throughout study treatment and compare between the two arms.
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
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.
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.

Full Information

First Posted
February 27, 2018
Last Updated
July 23, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Professional Compounding Centers of America
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1. Study Identification

Unique Protocol Identification Number
NCT03461354
Brief Title
MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Professional Compounding Centers of America

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis Oral, Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Mucolox Arm
Arm Title
B
Arm Type
Active Comparator
Arm Description
Sodium Bicarb Control Arm
Intervention Type
Other
Intervention Name(s)
MucoLox
Intervention Description
MucoLox formulation, with MucoLox as the delivery vehicle, combined with preserved water, beta-glucan, dexpanthenol, and glutamine
Intervention Type
Other
Intervention Name(s)
Sodium Bicarbonate
Intervention Description
Sodium bicarbonate oral rinse
Primary Outcome Measure Information:
Title
AUC for the Oral Mucositis Daily Questionnaire mouth and throat soreness question #2
Description
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
Secondary Outcome Measure Information:
Title
Time to OMDQ MTS > 2
Description
To compare the time to OMDQ MTS Q2 > 2 between the two arms
Time Frame
One month
Title
Opioid use (morphine equivalent daily dose)
Description
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
Title
Assess remaining OMDQ questions
Description
To assess changes in the remaining OMDQ questions longitudinally throughout study treatment and compare between the two arms.
Time Frame
One month
Title
Duration of symptom relief
Description
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
Title
Frequency of chemoradiation delays
Description
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
Title
Oral mucositis grade
Description
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
Other Pre-specified Outcome Measures:
Title
Drug-related adverse events
Description
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.
Time Frame
One month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Subjects must meet all of the following criteria: Confirmed head/neck cancer scheduled to receive at least a 28-day course of radiation to the head/neck area (radiation field must include at least one mucosal site within the oral cavity space, oropharynx, hypopharynx or larynx). Subjects must be planned to receive a minimum cumulative dose of 40 Gy and maximum dose of 72 Gy of radiation. Subjects may or may not be scheduled to receive concomitant platinum-based chemotherapy administered with radiation At least 18 years of age ECOG performance status less than or equal to 2 or Karnofsky performance score greater than or equal to 70%. Able and willing to complete OMDQ as determined by the treating Investigator Able and willing to swish/spit the oral formulation as determined by the treating Investigator Able and willing to provide informed consent Exclusion Criteria Subjects must not meet any of the following criteria: Receiving any other pharmacological treatment within 1 week of initiation of study treatment for oral mucositis, excluding analgesics, antibiotics, antifungals, and hydration for symptom management. Subjects must also agree to not use any other mouthwash formulations to prevent or treat mucositis during the course of the study. The subject's enrolling investigator must agree to not prescribe any other mouthwash formulations to prevent or treat oral mucositis during protocol-directed treatment (Note: subjects may receive standard of care treatment if the subject develops oral mucositis and discontinues study treatment [or may crossover to Arm A if randomized to Arm B]). Subjects must also agree to not use any other mouthwash formulations to prevent or treat oral mucositis during protocol-defined treatment. i. Agents suggested to modify oral mucositis risk or course that are not allowed include sodium bicarbonate, magic mouthwash formulations, amifostine, benzydamine, cevimeline, glutamine rinse, topical GM-CSF, interleukin-11, chlorhexidine, hydrogen peroxide, diphenhydramine, palifermin, pilocarpine, steroid rinses, sucralfate, and various oral rinse medical devices Untreated or unresolved oral infections, including oral candidiasis or active lesions due to oral herpes simplex virus infection that in the opinion of the investigator would compromise study outcomes. Signs and symptoms of any mouth and/or throat condition or active dental disease that would impair the ability to administer the mouthwash and/or assess the development of oral mucositis, as determined by the Investigator. Presence of baseline grade > 1 oral mucositis per WHO criteria as determined by the treating investigator Receiving chronic immunosuppression as determined by the Investigator Known hypersensitivity to any ingredients in the mouthwash formulations that may result in anaphylaxis. Use, or suspicion of use, of illicit drugs or substances (self-reported) that may, in the opinion of the Investigator, have a reasonable chance of contributing to non-compliance, opioid abuse, drug toxicity, and/or otherwise skewing the trial result
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tia Riley
Phone
704-403-0501
Email
Tia.Riley@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jai Patel, PharmD, BCOP
Organizational Affiliation
Levine Cancer Institute, Atrium Health (formerly Carolinas HealthCare System)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tia Riley
Phone
704-403-0501
Email
Tia.Riley@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Jai N Patel, PharmD, BCOP

12. IPD Sharing Statement

Plan to Share IPD
No

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MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

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