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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

Oral Mucositis

Study Interventions

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

Study Arms

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.

Study Status

Recruiting

Start Date: August 2012

Completed Date: August 2018

Phase: Phase 1

Type: Interventional

Design:

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

More information:https://clinicaltrials.gov/show/NCT01668849

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