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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668849
• Other study ID #: 12.0220
• Status: Completed
• Phase: Phase 1
• Start date: August 2, 2012
• Est. completion date: June 3, 2022

Study information

• Verified date: August 2022
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 3, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Oral Mucositis
• Stomatitis

Intervention

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

Locations

Country	Name	City	State
United States	James Graham Brown Cancer Center	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	James Graham Brown Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain caused by oral mucositis	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	Level of immune biomarkers in blood	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.
Secondary	Level of immune biomarkers in mucosal tissue	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.

External Links

•   James Graham Brown Cancer Center, Louisville, Kentucky