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

Primary Purpose

Head and Neck Cancer, Oral Mucositis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Grape extract
Lortab, Fentanyl patch, mouthwash
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring Plant exosomes, Grape exosomes, Grape extract, Oral mucositis, Head and Neck Cancer, Immune response

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • James Graham Brown Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 - Grape extract

2 - Lortab, Fentanyl patch, mouthwash

Arm Description

Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.

Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.

Outcomes

Primary Outcome Measures

Pain caused by oral mucositis
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
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
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.

Full Information

First Posted
August 6, 2012
Last Updated
August 5, 2022
Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01668849
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2012 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
June 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
James Graham Brown Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Oral Mucositis
Keywords
Plant exosomes, Grape exosomes, Grape extract, Oral mucositis, Head and Neck Cancer, Immune response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 - Grape extract
Arm Type
Experimental
Arm Description
Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.
Arm Title
2 - Lortab, Fentanyl patch, mouthwash
Arm Type
Active Comparator
Arm Description
Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.
Intervention Type
Dietary Supplement
Intervention Name(s)
Grape extract
Intervention Description
Grape extract self-administered by mouth daily for 35 days
Intervention Type
Drug
Intervention Name(s)
Lortab, Fentanyl patch, mouthwash
Other Intervention Name(s)
Lortab 5-10 mg, Fentanyl patch 25 mcgs, Mary's Magic Mouthwash
Intervention Description
Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash
Primary Outcome Measure Information:
Title
Pain caused by oral mucositis
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.
Time Frame
Total followup of six months
Secondary Outcome Measure Information:
Title
Level of immune biomarkers in blood
Description
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.
Time Frame
Within three days of the completion of radiation therapy which will last approximately 30 days.
Title
Level of immune biomarkers in mucosal tissue
Description
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.
Time Frame
Within three days of the completion of radiation therapy which will last approximately thirty days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Redman, MD
Organizational Affiliation
James Graham Brown Cancer Center, University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29054476
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.
Results Reference
derived
Links:
URL
http://www.browncancercenter.org
Description
James Graham Brown Cancer Center, Louisville, Kentucky

Learn more about this trial

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

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