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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


Phase 1
20 Years
85 Years
Open (Enrolling)
Both
Head and Neck Cancer, Oral Mucositis

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pain caused by oral mucositis

Outcome Description:

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.

Outcome Time Frame:

Total followup of six months

Safety Issue:

No

Principal Investigator

Donald M Miller, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center, University of Louisville

Authority:

United States: Institutional Review Board

Study ID:

12.0220

NCT ID:

NCT01668849

Start Date:

August 2012

Completion Date:

August 2017

Related Keywords:

  • Head and Neck Cancer
  • Oral Mucositis
  • Plant exosomes
  • Grape exosomes
  • Grape extract
  • Oral mucositis
  • Head and Neck Cancer
  • Immune response
  • Head and Neck Neoplasms
  • Stomatitis
  • Mucositis

Name

Location

James Graham Brown Cancer CenterLouisville, Kentucky  40202