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

August 5, 2022 updated by: Rebecca Redman, University of Louisville

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 - Grape extract
Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.
Dietary supplement: Grape extract
Grape extract self-administered by mouth daily for 35 days
Active Comparator: 2 - Lortab, Fentanyl patch, mouthwash
Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.
Drug: Lortab, Fentanyl patch, mouthwash
Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash
Other Names:
  • Lortab 5-10 mg
  • Fentanyl patch 25 mcgs
  • Mary's Magic Mouthwash

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain caused by oral mucositis
Time Frame: Total followup of six months
Extent of pain from oral mucositis will be evaluated weekly during treatment (6 to 7 weeks) and for six months following the completion of treatment which will last approximately 30 days.
Total followup of six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of immune biomarkers in blood
Time Frame: Within three days of the completion of radiation therapy which will last approximately 30 days.
Levels of immune biomarkers (cytokines, T cells NK Cells CD11cIL12)in the blood at the time of completion of radiation therapy will be compared to baseline levels.
Within three days of the completion of radiation therapy which will last approximately 30 days.
Level of immune biomarkers in mucosal tissue
Time Frame: Within three days of the completion of radiation therapy which will last approximately thirty days.
Levels of immune biomarkers (CD3, CD8, CD11b, F4/80, BRDU)in scrapings of mucosal tissue at the time of completion of radiation therapy will be compared to baseline levels.
Within three days of the completion of radiation therapy which will last approximately thirty days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center

Investigators

  • Principal Investigator: Rebecca Redman, MD, James Graham Brown Cancer Center, University of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2012

Primary Completion (Actual)

May 25, 2022

Study Completion (Actual)

June 3, 2022

Study Registration Dates

First Submitted

August 6, 2012

First Submitted That Met QC Criteria

August 16, 2012

First Posted (Estimate)

August 20, 2012

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 5, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12.0220

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Cancer

Clinical Trials on Grape extract

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe