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

University of Louisville (UOFL)

Status and phase: Completed; Phase 1

Conditions: Oral Mucositis; Head and Neck Cancer

Treatments: Drug: Lortab, Fentanyl patch, mouthwash; Dietary Supplement: Grape extract

Study type: Interventional

Funder types: Other

Identifiers

NCT01668849

12.0220

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1 - Grape extract

Experimental group

Description:

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

Treatment:

Dietary Supplement: Grape extract

2 - Lortab, Fentanyl patch, mouthwash

Active Comparator group

Description:

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

Treatment:

Drug: Lortab, Fentanyl patch, mouthwash