Clinical trial NCT01668849: Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Cancer
Oral Mucositis
Keywords: Plant exosomes
Grape exosomes
Grape extract
Oral mucositis
Head and Neck Cancer
Immune response
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2012-08-20
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain caused by oral mucositis
timeFrame: Total followup of six months
Secondary outcomes:
measure: Level of immune biomarkers in blood
timeFrame: Within three days of the completion of radiation therapy which will last approximately 30 days.
measure: Level of immune biomarkers in mucosal tissue
timeFrame: Within three days of the completion of radiation therapy which will last approximately thirty days.
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center, University of Louisville
name: Rebecca Redman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu K, Xing F, Wu SY, Watabe K. Extracellular vesicles as emerging targets in cancer: Recent development from bench to bedside. Biochim Biophys Acta Rev Cancer. 2017 Dec;1868(2):538-563. doi: 10.1016/j.bbcan.2017.10.001. Epub 2017 Oct 18.