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

NCT ID: NCT01668849

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-02
• Study Completion Date: 2022-06-03

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.

Conditions

Head and Neck Cancer; Oral Mucositis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 - Grape extract

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

Group Type: EXPERIMENTAL

Grape extract

Intervention Type: DIETARY_SUPPLEMENT

Grape extract self-administered by mouth daily for 35 days

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.

Group Type: ACTIVE_COMPARATOR

Lortab, Fentanyl patch, mouthwash

Intervention Type: DRUG

Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash

Interventions

Grape extract

Grape extract self-administered by mouth daily for 35 days

Intervention Type: DIETARY_SUPPLEMENT

Lortab, Fentanyl patch, mouthwash

Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash

Intervention Type: DRUG

Other Intervention Names

Lortab 5-10 mg; Fentanyl patch 25 mcgs; Mary's Magic Mouthwash

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

James Graham Brown Cancer Center

OTHER

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Redman

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Redman, MD

Role: PRINCIPAL_INVESTIGATOR

James Graham Brown Cancer Center, University of Louisville

Locations

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29054476 (View on PubMed)

Related Links

http://www.browncancercenter.org

James Graham Brown Cancer Center, Louisville, Kentucky

Other Identifiers

12.0220

Identifier Type: -

Identifier Source: org_study_id