Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer
This study is currently recruiting participants.
Verified April 2013 by James Graham Brown Cancer Center
Sponsor:
James Graham Brown Cancer Center
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 22, 2013
Last verified: April 2013
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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:
|
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
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 22, 2013 |
| 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 Stomatitis Mucositis Neoplasms by Site Neoplasms Mouth Diseases Stomatognathic Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Fentanyl Acetaminophen, hydrocodone drug combination Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013