NCT01668849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 head-and-neck-cancer

Timeline
Completed

Started Aug 2012

Longer than P75 for phase_1 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 2, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 20, 2012

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2022

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

9.8 years

First QC Date

August 6, 2012

Last Update Submit

August 5, 2022

Conditions

Head and Neck CancerOral Mucositis

Keywords

Plant exosomesGrape exosomesGrape extractOral mucositisHead and Neck CancerImmune response

Outcome Measures

Primary Outcomes (1)

  • 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.

    Total followup of six months

Secondary Outcomes (2)

  • Level of immune biomarkers in blood

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

  • Level of immune biomarkers in mucosal tissue

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

Study Arms (2)

1 - Grape extract

EXPERIMENTAL

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

Dietary Supplement: Grape extract

2 - Lortab, Fentanyl patch, mouthwash

ACTIVE COMPARATOR

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

Interventions

Grape extractDIETARY_SUPPLEMENT

Grape extract self-administered by mouth daily for 35 days

1 - Grape extract
Lortab, Fentanyl patch, mouthwashDRUG

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

Also known as: Lortab 5-10 mg, Fentanyl patch 25 mcgs, Mary's Magic Mouthwash
2 - Lortab, Fentanyl patch, mouthwash

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

  • 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.

    PMID: 29054476DERIVED

Related Links

MeSH Terms

Conditions

Head and Neck NeoplasmsStomatitis

Interventions

whole grape extractoxycodone-acetaminophenMouthwashes

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental MaterialsSpecialty Uses of ChemicalsChemical Actions and UsesCosmeticsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Rebecca Redman, MD

    James Graham Brown Cancer Center, University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 6, 2012

First Posted

August 20, 2012

Study Start

August 2, 2012

Primary Completion

May 25, 2022

Study Completion

June 3, 2022

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations

US(1)