Head and Neck Cancer | Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer
Head and Neck Cancer research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Head and Neck Cancer
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:Grape extractGrape extract self-administered by mouth daily for 35 days
Drug:Lortab, Fentanyl patch, mouthwashLortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1 - Grape extractGrape extract self-administered daily by mouth for 35 days during chemoradiation therapy.
2 - Lortab, Fentanyl patch, mouthwashStandard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.
Start Date: August 2012
Completed Date: August 2018
Phase: Phase 1
Primary Outcome: Pain caused by oral mucositis
Secondary Outcome: Level of immune biomarkers in blood
Study sponsors, principal investigator, and references
Principal Investigator: Rebecca Redman, MD
Lead Sponsor: James Graham Brown Cancer Center
Collaborator: University of Louisville