Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors
Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage I Squamous Cell Carcinoma of the Oropharynx, Stage I Verrucous Carcinoma of the Oral Cavity
About this trial
This is an interventional prevention trial for Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity focused on measuring black raspberry, Appalachia, oral cancer, cancer recurrence
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Arm I: BRB Lozenge
Arm II: Biomarker Control
Former oral cancer patients receive lozenges containing freeze-dried black raspberry (BRB) powder. They will take the lozenges four times each day (QID) by mouth (PO) for up to 6 months. Patients will be asked to complete a baseline survey documenting any family history of cancer, tobacco, alcohol, and mouthwash use, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) Survey, and a Brief Fatigue Inventory (BFI) Survey. They will receive a trial-specific logbook to record their usages. Intervention: Black Raspberry (BRB) Lozenge Intervention: Survey Administration Intervention: Laboratory Biomarker Analysis
Former oral cancer patients will not receive lozenges containing freeze-dried black raspberry (BRB) powder. Patients will be asked to complete a baseline survey documenting any family history of cancer, tobacco, alcohol, and mouthwash use, a Head and Neck Cancer Inventory Survey (HNCI), an Insomnia Severity Index (ISI) Survey, and a Brief Fatigue Inventory (BFI) Survey. They will receive a trial-specific logbook to record their usages. Intervention: Survey Administration Intervention: Laboratory Biomarker Analysis