Squamous Cell Carcinoma of Mouth Clinical Trial
Official title:
A Phase 1b Pilot Study Evaluating Oral Administration of Freeze-Dried Black Raspberries in Pre-Surgical Patients With Oral Squamous Cell Carcinoma
This pilot phase I trial studies freeze-dried black raspberries in treating patients with oral squamous cell cancer undergoing surgery. Chemoprevention is the use of certain drugs to keep cancer from forming. Eating freeze-dried black raspberries may help prevent or treat oral cancer
PRIMARY OBJECTIVES:
I. To determine the relationship between the length of short-term lyophilized black
raspberries (LBR) administration to human oral cancer patients and the modulation, in oral
cavity tissues, of a subset of specific genes previously identified by us to be
"LBR-responsive" and associated with LBR's chemopreventive activity.
SECONDARY OBJECTIVES:
I. To evaluate the effects of LBR administration in humans on cell proliferation, apoptosis,
and angiogenesis in oral cavity tissues using various established biomarkers including Ki-67
or proliferating cell nuclear antigen (PCNA), caspase-3, vascular endothelial growth factor
(VEGF) or basic fibroblast growth factor (bFGF).
II. To assess the feasibility of administering lyophilized freeze-dried black raspberries in
oral troche form to pre-surgical patients diagnosed with squamous cell carcinoma of the oral
cavity (compliance, tolerance, adverse events).
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Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01192204 -
Clinical Evaluation of Bioadhesive Gels for Oral Cancer Chemoprevention
|
Phase 1/Phase 2 | |
Completed |
NCT01314755 -
A Trial of Perioperative Immune Enhancing Feed in Patients Undergoing Surgery for Head and Neck Cancer
|
N/A |