Trials / Completed

CompletedNCT01504932

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

Pilot Long-Term Oral Dose of Freeze-Dried Black Raspberries in Post-Surgical Appalachian Oral Cancer

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 42 (actual)

Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
Sex: All
Age: 21 Years
Healthy volunteers: Accepted

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.

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 practicability of long-term daily freeze-dried black raspberry (BRB) (BRB lozenge) administration and to gain insights into the potential prevention of recurrent oral cancer by BRBs. SECONDARY OBJECTIVES: I. Evaluate numerous parameters (recruitment, tolerability, adherence to study guidelines, collection of biological samples, and demographics) that will be helpful in designing a future definitive, randomized, Phase II or III clinical trial structured to assess the potential effects of long-term BRB administration. II. Evaluate the temporal modulation of BRB-responsive gene expression that favor oral cancer chemoprevention in high at-at risk normal tissues before and after BRB administration. III. Assess the temporal modulation of BRB-responsive gene expression and biological levels of fruit components in post-surgical oral cancer patients not exposed to BRBs. OUTLINE: Patients are assigned to 1 of 2 treatment arms. ARM I: Patients receive freeze-dried black raspberry lozenges orally (PO) 4 times daily (QID) for up to 6 months. ARM II: Patients do not receive freeze-dried black raspberries lozenges. After completion of study treatment, patients in Arm I are followed for up to 5 years and patients in Arm II are followed for up to 1 year for oral cancer recurrence.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2007-02-23
Primary completion: 2015-04-22
Completion: 2015-04-22
First posted: 2012-01-06
Last updated: 2020-02-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01504932. Inclusion in this directory is not an endorsement.