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MucoLox for Mucositis in Head/Neck Cancer
N/A
Waitlist Available
Led By Jai Patel, PharmD, BCOP
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status less than or equal to 2 or Karnofsky performance score greater than or equal to 70%
At least 18 years of age
Must not have
Signs and symptoms of any mouth and/or throat condition or active dental disease that would impair the study
Receiving chronic immunosuppression
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly during the one month study period
Awards & highlights
No Placebo-Only Group
Summary
This trial will study if MucoLox can prevent severe mucositis in head/neck cancer patients receiving radiation and/or chemotherapy.
Who is the study for?
Adults with head/neck cancer scheduled for radiation (possibly with chemotherapy) who can perform mouthwash routines and complete questionnaires. They must have a performance status allowing daily activities and be able to consent. Excluded are those on chronic immunosuppression, using other mucositis treatments, or having active oral infections.
What is being tested?
The trial is testing whether MucoLox, a new mouthwash formulation, is more effective than sodium bicarbonate in preventing severe mucositis in patients undergoing radiation therapy for head/neck cancer.
What are the potential side effects?
Potential side effects may include allergic reactions to ingredients in the MucoLox or sodium bicarbonate formulations. Since these are topical treatments, systemic side effects are less likely but could still occur depending on individual sensitivities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mostly able to care for myself and carry out daily activities.
Select...
I am 18 years old or older.
Select...
I have head or neck cancer and will undergo radiation for at least 28 days.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any mouth, throat, or dental issues that could affect the study.
Select...
I am on long-term medication to suppress my immune system.
Select...
I do not have any untreated mouth infections.
Select...
I have moderate to severe mouth sores.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weekly during the one month study period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly during the one month study period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AUC for the Oral Mucositis Daily Questionnaire mouth and throat soreness question #2
Secondary study objectives
Assess remaining OMDQ questions
Comparison of self-reported OMDQ scores versus investigator-assessed mucositis
Duration of symptom relief
+4 moreOther study objectives
Drug-related adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AExperimental Treatment1 Intervention
Mucolox Arm
Group II: BActive Control1 Intervention
Sodium Bicarb Control Arm
Find a Location
Who is running the clinical trial?
Atrium Health Levine Cancer InstituteOTHER
26 Previous Clinical Trials
3,603 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,390 Previous Clinical Trials
2,546,575 Total Patients Enrolled
1 Trials studying Oral Mucositis
60 Patients Enrolled for Oral Mucositis
Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,873 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swish and spit medicine as my doctor thinks is okay.I haven't taken any drugs for mouth sores in the last week, except for certain allowed ones.I am mostly able to care for myself and carry out daily activities.I do not have any mouth, throat, or dental issues that could affect the study.I am 18 years old or older.I have head or neck cancer and will undergo radiation for at least 28 days.I am on long-term medication to suppress my immune system.I do not have any untreated mouth infections.I have moderate to severe mouth sores.
Research Study Groups:
This trial has the following groups:- Group 1: A
- Group 2: B
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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