Neoplasms

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Head and Neck Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Adjuvants, Anesthesia

Analgesics

Central Nervous System Depressants

All Drugs and Chemicals

Anti-Infective Agents

Anti-Inflammatory Agents

Antirheumatic Agents

Antipyretics

Antitussive Agents

Respiratory System Agents

Herbal and Botanical

Fentanyl

Clotrimazole

Miconazole

Antifungal Agents

Acetaminophen, hydrocodone drug combination

Acetaminophen

Hydrocodone

Analgesics, Opioid

Narcotics

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Grape

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.

Grape extract self-administered by mouth daily for 35 days

Grape extract

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

Lortab, Fentanyl patch, mouthwash

Rebecca Redman, MD

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.

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.

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

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

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.

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.

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.

James Graham Brown Cancer Center

University of Louisville

Associate Professor

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

Antineoplastic Agents

Curcumin

Enzyme Inhibitors

Cola

Subjects take curcumin conjugated with plant exosomes.

subjects will not take curcumin or plant exosomes

tablets-3.6 gram (gm) taken daily for 7 days - 15 subjects

curcumin

tablets-taken daily for 7 days - 15 subjects

Curcumin conjugated with plant exosomes

No intervention

Gerald W Dryden Jr, MD, Ph.D

Gerald W Dryden, MD, Ph.D

Gerald W Dryden Jr, MD, PhD

This clinical trial will investigate the ability of plant exosomes to more effectively deliver curcumin to normal colon tissue and colon tumors. Curcumin is the yellow pigment of turmeric, a natural product with diverse biological activities. Exosomes are small endosome-derived vesicles (50-100 nanometers \[nm\] in size). Previous clinical trials conducted with oral curcumin have demonstrated only limited bioavailability even at very high doses of 8-12 grams per day. This trial plans to address this problem of curcumin delivery by using plant exosomes to deliver the drug to colon tumors and normal colon tissue.

Curcumin is a constituent of the spice turmeric, which is one of the primary ingredients of curry powder. Curcumin has been shown to interfere with colon carcinogenesis in a variety of chemical and genetic rodent models. It has also been shown to have a strong inhibitory effect on the growth of colon cancer cell lines. There is considerable evidence that the effects of curcumin are mediated by changes in signal transduction. There is an extensive body of work showing effects on several signaling pathways, including the beta-catenin and NF-κB pathways. Although curcumin has been viewed as an ideal chemopreventative agent in colon cancer for many years, its application has been impeded by important issues with drug delivery and bioavailability in the reported clinical trials of this compound.

Work from the James Graham Brown Cancer Center published recently suggests that using exosomes as a delivery vehicle leads to overcoming all the major obstacles of using curcumin as an anti-inflammatory agent, including increased stability, solubility, and bioavailability of curcumin. The work was further extended to define the resource that can supply a large quantity of exosomes with a maximum binding capacity of curcumin. Emerging data indicate that exosomes derived from many fruits release exosome-like particles, strongly bind to many hydrophobic drugs including curcumin, and are taken up by the intestine cells as well as the immune cells in the intestine. These results suggest that these fruit-derived exosomes are potentially used as a delivery vehicle to treatment of intestinal diseases. Moreover, both fruit exosomes and curcumin should not generate any side-effects since they are consumed by humans daily.

In this clinical trial, the effect of exosomally delivered curcumin on the immune modulation, cellular metabolism, and phospholipid profile of normal and malignant colon cells in subjects who are undergoing surgery for newly diagnosed colon cancer will be characterized. In selected subjects, the effect of exosomally delivered curcumin on the production of cytokines, the changes of immune cells, and glucose metabolism by administration of 13C-glucose prior to surgical resection will also be characterized.

curcumin alone in capsule form (Arm 1) curcumin combined with plant exosomes (Arm 2) will not take curcumin or plant exosomes (Arm 3)

Study Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Colon Cancer Tissue

Phase I Clinical Trial Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Malignant Colon Tissue

Concentration of curcumin delivered with curcumin alone or curcumin conjugated with plant exosomes to normal and cancerous colon cells will be compared. This exploratory trial is designed to estimate the effect of a fixed concentration of curcumin when delivered by plant exosomes compared to oral tablets of curcumin alone.

Curcumin and plant exosomes will be taken orally.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer	NCT01668849	Head and Neck C... Oral Mucositis	Grape extract Lortab, Fentany...	20 Years - 85 Years	University of Louisville
Edible Plant Exosome Ability to Prevent Oral Mucositis Associated With Chemoradiation Treatment of Head and Neck Cancer	NCT01668849	Head and Neck C... Oral Mucositis	Grape extract Lortab, Fentany...	20 Years - 85 Years	University of Louisville
Study Investigating the Ability of Plant Exosomes to Deliver Curcumin to Normal and Colon Cancer Tissue	NCT01294072	Colon Cancer	curcumin Curcumin conjug... No intervention	20 Years -	University of Louisville

Spots Global Cancer Trial Database for plant exosomes