NCT01504932View on ClinicalTrials.gov

Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors

NACompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

February 23, 2007

Primary Completion Date

April 22, 2015

Study Completion Date

April 22, 2015

Conditions
Stage I Squamous Cell Carcinoma of the Lip and Oral CavityStage I Squamous Cell Carcinoma of the OropharynxStage I Verrucous Carcinoma of the Oral CavityStage II Squamous Cell Carcinoma of the Lip and Oral CavityStage II Squamous Cell Carcinoma of the OropharynxStage II Verrucous Carcinoma of the Oral CavityStage III Squamous Cell Carcinoma of the Lip and Oral CavityStage III Squamous Cell Carcinoma of the OropharynxStage III Verrucous Carcinoma of the Oral CavityStage IVA Squamous Cell Carcinoma of the Lip and Oral CavityStage IVA Squamous Cell Carcinoma of the OropharynxStage IVA Verrucous Carcinoma of the Oral CavityStage IVB Squamous Cell Carcinoma of the Lip and Oral CavityStage IVB Squamous Cell Carcinoma of the OropharynxStage IVB Verrucous Carcinoma of the Oral CavityStage IVC Squamous Cell Carcinoma of the Lip and Oral CavityStage IVC Squamous Cell Carcinoma of the OropharynxStage IVC Verrucous Carcinoma of the Oral CavityTongue Cancer
Interventions
DIETARY_SUPPLEMENT

BRB Lozenge

ARM I: Patients will be instructed to begin BRB administration and continue daily for up to 6 months.

OTHER

Survey Administration

Patients will complete a baseline survey documenting any family history of cancer. Patients will then provide a history of tobacco, alcohol and mouthwash use, complete the Head and Neck Cancer Inventory Survey (HNCI), the Insomnia Severity Index (ISI) Survey, and the Brief Fatigue Inventory (BFI) Survey. Patients will receive a trial-specific logbook to record their usages.

OTHER

Laboratory Biomarker Analysis

Patients will provide blood, urine, saliva, and cheek scrape samples. These biological samples will be evaluated for the presence of BRB components (as a measure of compliance) and assessed for BRB-responsive gene expression, respectively.

OTHER

pharmacological study

Correlative studies

Trial Locations (1)

43210

Ohio State University Medical Center, Columbus

All Listed Sponsors
lead

Ohio State University Comprehensive Cancer Center

OTHER

NCT01504932 - Freeze-Dried Black Raspberries in Preventing Oral Cancer Recurrence in High At-Risk Appalachian Patients Oral Cancer Survivors | Biotech Hunter | Biotech Hunter