NCT03461354

MucoLox Formulation to Mitigate Mucositis Symptoms in Head/Neck Cancer

Terminated NA Last updated 6 February 2025

What this trial tests

NA trial testing MucoLox in Mucositis Oral in 49 participants. Terminated before completion.

Timeline

9 April 2018

Primary endpoint
1 April 2024

1 April 2024

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	49
Start date	9 April 2018
Primary completion	1 April 2024
Estimated completion	1 April 2024
Sites	1 location across United States

Drugs / interventions tested

• MucoLox
• Sodium Bicarbonate (Sodium Bicarbonate) — full drug profile →

Conditions studied

• Mucositis Oral — all drugs for Mucositis Oral →
• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

Wake Forest University Health Sciences

Who can join

18 and older, any sex, with Mucositis Oral or Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Translational Applications of Hydrogels.
   Correa S, Grosskopf AK, Lopez Hernandez H, Chan D, et al · · 2021 · cited 575× · PMID 33938724 · DOI 10.1021/acs.chemrev.0c01177
2. β-Glucan Metabolic and Immunomodulatory Properties and Potential for Clinical Application.
   Murphy EJ, Rezoagli E, Major I, Rowan NJ, et al · · 2020 · cited 121× · PMID 33322069 · DOI 10.3390/jof6040356
3. Drug Delivery Strategies and Biomedical Significance of Hydrogels: Translational Considerations.
   Raina N, Pahwa R, Bhattacharya J, Paul AK, et al · · 2022 · cited 79× · PMID 35335950 · DOI 10.3390/pharmaceutics14030574
4. Pathogenesis and Amelioration of Radiation-Induced Oral Mucositis.
   Lee CT, Galloway TJ. · · 2022 · cited 32× · PMID 35244887 · DOI 10.1007/s11864-022-00959-z
5. The Neutrophil: The Underdog That Packs a Punch in the Fight against Cancer.
   Ustyanovska Avtenyuk N, Visser N, Bremer E, Wiersma VR. · · 2020 · cited 27× · PMID 33105656 · DOI 10.3390/ijms21217820
6. Biocompatible Polymer Nano-Constructs: A Potent Platform for Cancer Theranostics.
   Kalita H, Patowary M. · · 2023 · cited 5× · PMID 36855787 · DOI 10.1177/15330338231160391