Freeze-Dried Black Raspberries in Treating Patients With Oral Squamous Cell Cancer Undergoing Surgery

Amit Agrawal

Status

Completed

Conditions

Squamous Cell Carcinoma of Mouth

Treatments

Other: laboratory biomarker analysis

Other: preventative dietary intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01465776

NCI-2011-02684 (Registry Identifier)

OSU-0497

Details and patient eligibility

About

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

Full description

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).

Enrollment

38 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with newly diagnosed, biopsy-proven previously untreated squamous cell carcinoma (SCC) of the oral cavity (stages I - IV); suspected cases of SCC will be allowed if biopsy is performed and results of SCC confirmed on subsequent histopathologic analysis (i.e. frozen section) prior to enrollment and initiation of LBR administration
Patients must already be planned for surgical resection of their tumor (prior to being considered eligible for this study)
Patients must be able to take nutrition/medications orally
No prior history of intolerance or allergy to berry or berry-containing products

Exclusion criteria

History of intolerance (including hypersensitivity or allergy) to berry or berry-containing products
Known history of bleeding disorder or patient on systemic anticoagulation therapy (i.e. coumadin, heparin) for purposes of the study biopsy
Pregnant women; although there are no known adverse effects of black raspberries upon the fetus, if patients become pregnant during period of LBR administration, then LBR will be discontinued and patient will be removed from the study
Inability to grant informed consent
Patients must not be planning to receive chemotherapy or radiation therapy prior to their surgery or this will affect endpoint analysis and these patients will be excluded from the study
Patients taking cyclooxygenase (COX)-I or COX-2 inhibitors, who cannot be taken off the medication due to their clinical condition will be excluded given that these agents may interfere with biomarkers studied
Vegetarians will be excluded from the study since we anticipate that this patient population will have difficulty adhering to a low-phenolic diet (restricts basically all plant-based foods)