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MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

NCT03461354 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

Interventions

OTHER

MucoLox

MucoLox formulation, with MucoLox as the delivery vehicle, combined with preserved water, beta-glucan, dexpanthenol, and glutamine

OTHER

Sodium Bicarbonate

Sodium bicarbonate oral rinse

Sponsors & Collaborators

  • Professional Compounding Centers of America

    collaborator INDUSTRY

  • Atrium Health Levine Cancer Institute

    collaborator OTHER

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Jai Patel, PharmD, BCOP · Levine Cancer Institute, Atrium Health (formerly Carolinas HealthCare System)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-09
Primary Completion
2024-04-01
Completion
2024-04-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03461354 on ClinicalTrials.gov