Completed

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

What is being tested

Grape extract

+ Lortab, Fentanyl patch, mouthwash

Dietary SupplementDrug

Who is being recruted

Head and Neck Neoplasms+3

+ Stomatognathic Diseases

+ Mouth Diseases

From 20 to 85 Years

+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: August 2012

See protocol details

Summary

Principal SponsorUniversity of Louisville

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 2, 2012

Actual date on which the first participant was enrolled.

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.

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

NCT01668849

Principal SponsorUniversity of Louisville

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Head and Neck NeoplasmsStomatognathic DiseasesMouth DiseasesNeoplasmsNeoplasms by SiteStomatitis

Criteria

8 inclusion criteria required to participate

Patients must have definitive diagnosis of head and neck cancer.

Concurrent chemoradiation treatment of the primary tumor must be an option for the newly diagnosed cancer.

Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.

Absence of life limiting medical conditions

Show More Criteria

8 exclusion criteria prevent from participating

Known familial head and neck cancer syndrome

Pregnancy

Known HIV

Patients receiving immunosuppressive drugs

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.

Group II

Active Comparator

Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

James Graham Brown Cancer Center

Louisville, United StatesOpen James Graham Brown Cancer Center in Google Maps

CompletedOne Study Center