NCT01668849

Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer

Preliminary Clinical Trial Investigating the Ability of Plant Exosomes to Abrogate Oral Mucositis Induced by Combined Chemotherapy and Radiation in Head and Neck Cancer Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the ability of grape exosomes, given to the subject as grape powder, as an important anti-inflammatory agent to reduce the incidence of oral mucositis during radiation and chemotherapy treatment for head and neck tumors.

Detailed description

The purpose of this study is to investigate the ability of plant (grape) exosomes to prevent oral mucositis associated with chemoradiation treatment of head and neck cancer. Also, to be evaluated is the effect of grape exosomes on the production of cytokines and immune responses to tumor exosomal antigens, metabolic and molecular markers in these patients.

Conditions

• Head and Neck Cancer
• Oral Mucositis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Grape extract	Grape extract self-administered by mouth daily for 35 days
DRUG	Lortab, Fentanyl patch, mouthwash	Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash

Timeline

• Start date: 2012-08-02
• Primary completion: 2022-05-25
• Completion: 2022-06-03
• First posted: 2012-08-20
• Last updated: 2022-08-09

Locations

1 site across 1 country: United States