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Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT01668849•University of Louisville

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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
•Ability to understand and willingness to sign a written informed consent document.
•ECOG performance status 0, 1, or 2 (Karnofsky \> 60%).
•Patients must have adequate bone marrow function. ANC \> 1000/microL and Platelet count \>100,000/microL
•Age \>20 years

Exclusion Criteria

•Known familial head and neck cancer syndrome
•Pregnancy
•Known HIV
•Patients receiving immunosuppressive drugs
•Inflammatory bowel disease
•Active second malignancy in the last 5 years
•Patients receiving any other investigational agent(s)
•Patients who have received any prior chemotherapy or radiation therapy to the primary head and neck cancer

Locations (1)

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Key Dates

Start Date

August 2, 2012

Primary Completion Date

May 25, 2022

Completion Date

June 3, 2022

Last Updated

August 9, 2022

Enrollment

ACTUAL participants

Conditions

Head and Neck CancerOral Mucositis

Interventions

Grape extract

DIETARY_SUPPLEMENT

Lortab, Fentanyl patch, mouthwash

DRUG

Prevention of Oral Mucositis in Head and Neck Cancer.

NCT05853692

Oral Mucositis

View study

RECRUITINGPHASE1/PHASE2

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

NCT04585750

Advanced Solid TumorAdvanced Malignant Neoplasm+28 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Prevention of Oral Mucositis in Head and Neck Cancer.

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

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