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

Phase 1

Completed

• Conditions: Head and Neck Cancer; Oral Mucositis
• Interventions: Dietary Supplement: Grape extract; Drug: Lortab, Fentanyl patch, mouthwash

• Registration Number: NCT01668849
• Lead Sponsor: University of Louisville

Brief 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.

Study Timeline

• Study Start: 2012-08-02
• Study First Submitted: 2012-08-06
• Study First Submitted QC: 2012-08-16
• Study First Posted: 2012-08-20
• Primary Completion: 2022-05-25
• Study Completion: 2022-06-03
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-05
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 - Grape extract	Grape extract	Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.
2 - Lortab, Fentanyl patch, mouthwash	Lortab, Fentanyl patch, mouthwash	Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.

Primary Outcome Measures

Name	Time	Method
Pain caused by oral mucositis	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.

Secondary Outcome Measures

Name	Time	Method
Level of immune biomarkers in blood	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.
Level of immune biomarkers in mucosal tissue	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.

Trial Locations

Locations (1)

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States