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Completed

NCT Number: NCT01668849

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

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Mouth Diseases Neoplasms Neoplasms by Site Oral Mucositis Stomatitis Stomatognathic Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Grape extract

Dietary Supplement

Grape extract self-administered by mouth daily for 35 days

Lortab, Fentanyl patch, mouthwash

Drug

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

Primary outcomes

  1. Pain caused by oral mucositis

    Time frame: Total followup of six months

    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 outcomes

  1. Level of immune biomarkers in blood

    Time frame: Within three days of the completion of radiation therapy which will last approximately 30 days.

    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.

  2. Level of immune biomarkers in mucosal tissue

    Time frame: Within three days of the completion of radiation therapy which will last approximately thirty days.

    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.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • James Graham Brown Cancer Center

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2022
Study completion
2022
First posted
Aug 20, 2012
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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