Status:
COMPLETED
Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity
Stage I Squamous Cell Carcinoma of the Oropharynx
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This pilot clinical trial studies freeze-dried black raspberries (BRB) in preventing oral cancer recurrence in high at-risk Appalachian patients previously treated with surgery for oral cancer. Chemop...
Detailed Description
PRIMARY OBJECTIVES: I. To conduct an initial early phase clinical study utilizing a high ar-risk and underserved Appalachian population who are former oral cancer patients to determine the practicabi...
Eligibility Criteria
Inclusion
- Patients from any Appalachian County with previously diagnosed, biopsy-proven, surgically resected, oral squamous cell carcinoma (SCC) (stages T1 to T4), which encompasses cancers of the oral cavity including lips, buccal mucosa, teeth, floor of the mouth and gums and those of the oropharynx consisting of the base of the tongue, soft palate, tonsillar area, and the posterior pharyngeal wall will be eligible
- Patients who have followed the advice of their physician and have been definitively treated for their tumor by any method and are currently disease free will be eligible
- Patients may be enrolled as early as their first follow-up post-operative clinic visit after their most recent surgery, but no more than 36 months post-surgery
- 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
- Patients who are actively receiving adjuvant therapy (radiation, chemotherapy) will be excluded until such time as they have completed treatments
- 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
Key Trial Info
Start Date :
February 23 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2015
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01504932
Start Date
February 23 2007
End Date
April 22 2015
Last Update
February 20 2020
Active Locations (1)
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1
Ohio State University Medical Center
Columbus, Ohio, United States, 43210