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

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. Chemoprevention is the use of drugs natural products to keep cancer from developing, progressing, or recurring. Giving freeze-dried black raspberries may prevent oral cancer from forming or returning in oral cancer survivors.

Conditions

• 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
• Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage II Squamous Cell Carcinoma of the Oropharynx
• Stage II Verrucous Carcinoma of the Oral Cavity
• Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage III Squamous Cell Carcinoma of the Oropharynx
• Stage III Verrucous Carcinoma of the Oral Cavity
• Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IVA Squamous Cell Carcinoma of the Oropharynx
• Stage IVA Verrucous Carcinoma of the Oral Cavity
• Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IVB Squamous Cell Carcinoma of the Oropharynx
• Stage IVB Verrucous Carcinoma of the Oral Cavity
• Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity
• Stage IVC Squamous Cell Carcinoma of the Oropharynx
• Stage IVC Verrucous Carcinoma of the Oral Cavity
• Tongue 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Amit Agrawal, MD · Ohio State University

Study Design

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-02-23

Primary Completion

2015-04-22

Completion

2015-04-22

Countries

• United States

Study Locations