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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 below
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I am mostly able to care for myself and carry out daily activities.
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I am 18 years old or older.
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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:
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I do not have any mouth, throat, or dental issues that could affect the study.
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I am on long-term medication to suppress my immune system.
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I do not have any untreated mouth infections.
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I have moderate to severe mouth sores.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weekly during the one month study period
This trial's timeline: 3 weeks for screening, Varies for treatment, and weekly during the one month study period for reporting.

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 more
Other 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
27 Previous Clinical Trials
3,733 Total Patients Enrolled
Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,477,875 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
Professional Compounding Centers of AmericaIndustry Sponsor
Jai Patel, PharmD, BCOPPrincipal Investigator - Levine Cancer Institute, Atrium Health (formerly Carolinas HealthCare System)
Atrium Health

Media Library

MucoLox (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03461354 — N/A
Oral Mucositis Research Study Groups: A, B
Oral Mucositis Clinical Trial 2023: MucoLox Highlights & Side Effects. Trial Name: NCT03461354 — N/A
MucoLox (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03461354 — N/A
~2 spots leftby Apr 2025
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