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MucoLox for Mucositis in Head/Neck Cancer

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly during the one month study period
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC for the Oral Mucositis Daily Questionnaire mouth and throat soreness question #2
Secondary outcome measures
Assess remaining OMDQ questions
Duration of symptom relief
Frequency of chemoradiation delays
+3 more
Other outcome measures
Drug-related adverse events

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?

Wake Forest University Health SciencesLead Sponsor
1,235 Previous Clinical Trials
1,001,936 Total Patients Enrolled
1 Trials studying Oral Mucositis
60 Patients Enrolled for Oral Mucositis
Professional Compounding Centers of AmericaIndustry Sponsor
Atrium HealthLead Sponsor
121 Previous Clinical Trials
34,938 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many human participants are included in this clinical experiment?

"Affirmative. According to the records found on clinicaltrials.gov, this medical trial opened for recruitment on March 15th 2018 and is still ongoing today. The study requires 60 patients from 1 location."

Answered by AI

Are recruitments for this research protocol still taking place?

"Affirmative. Clinicaltrials.gov attests that this medical trial is open for recruitment, with the original post date being 15th March 2018 and updates made on 10th September 2022. Sixty volunteers are currently required at a single research centre."

Answered by AI

Are there any existing precedents for MucoLox experimentation?

"At present, there are 20 ongoing clinical studies examining the efficacy of MucoLox with 1 in Phase 3. The hub for these investigations is Decatur, Georgia but research sites span across 29 locations nationwide."

Answered by AI

What conditions is MucoLox employed to treat?

"MucoLox is typically prescribed for barbiturate treatment, but it can also provide relief to patients with helicobacter infections, acute diarrhea and dental plaque."

Answered by AI
~9 spots leftby Apr 2025