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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by James Graham Brown Cancer Center
Sponsor:
Collaborator:
University of Louisville
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT01668849
First received: August 6, 2012
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Oral Mucositis
Dietary Supplement: Grape extract
Drug: Lortab, Fentanyl patch, mouthwash
Phase 1

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

Resource links provided by NLM:


Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:
  • Pain caused by oral mucositis [ Time Frame: Total followup of six months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Level of immune biomarkers in blood [ Time Frame: Within three days of the completion of radiation therapy which will last approximately 30 days. ] [ Designated as safety issue: No ]
    Levels of immune biomarkers (cytokines, T cells NK Cells CD11cIL12)in the blood at the time of completion of radiation therapy will be compared to baseline levels.

  • Level of immune biomarkers in mucosal tissue [ Time Frame: Within three days of the completion of radiation therapy which will last approximately thirty days. ] [ Designated as safety issue: No ]
    Levels of immune biomarkers (CD3, CD8, CD11b, F4/80, BRDU)in scrapings of mucosal tissue at the time of completion of radiation therapy will be compared to baseline levels.


Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 - Grape extract
Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.
Dietary Supplement: Grape extract
Grape extract self-administered by mouth daily for 35 days
Active Comparator: 2 - Lortab, Fentanyl patch, mouthwash
Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.
Drug: Lortab, Fentanyl patch, mouthwash
Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash
Other Names:
  • Lortab 5-10 mg
  • Fentanyl patch 25 mcgs
  • Mary's Magic Mouthwash

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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668849

Contacts
Contact: Donald M Miller, MD, PhD 502-562-4370 donaldmi@ulh.org
Contact: Karen M Carter, BA, BSN 502-562-3690 kmcart05@louisville.edu

Locations
United States, Kentucky
James Graham Brown Cancer Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Donald M Miller, MD, PhD    502-562-3429    donaldmi@ulh.org   
Contact: Karen M Carter, BA, BSN    502-562-3429    kmcart05@louisville.edu   
Principal Investigator: Donald M Miller, MD, PhD         
Sub-Investigator: Jeffrey M Bumpous, MD, FACS         
Sub-Investigator: Craig L Silverman, MD         
Sub-Investigator: Rebecca A Redman, MD         
Sponsors and Collaborators
James Graham Brown Cancer Center
University of Louisville
Investigators
Principal Investigator: Donald M Miller, MD, PhD James Graham Brown Cancer Center, University of Louisville
  More Information

Additional Information:
No publications provided

Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT01668849     History of Changes
Other Study ID Numbers: 12.0220
Study First Received: August 6, 2012
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by James Graham Brown Cancer Center:
Plant exosomes
Grape exosomes
Grape extract
Oral mucositis
Head and Neck Cancer
Immune response

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Mouth Diseases
Neoplasms
Neoplasms by Site
Stomatognathic Diseases
Acetaminophen, hydrocodone drug combination
Fentanyl
Adjuvants, Anesthesia
Analgesics
Analgesics, Non-Narcotic
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014