Status:
COMPLETED
Freeze-Dried Black Raspberries in Treating Patients With Oral Squamous Cell Cancer Undergoing Surgery
Lead Sponsor:
Amit Agrawal
Conditions:
Squamous Cell Carcinoma of Mouth
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed 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 cavi...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 10 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 16 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01465776
Start Date
January 10 2005
End Date
February 16 2010
Last Update
March 6 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210