Pilot Long-Term Oral Dose of Freeze-Dried Black Raspberries in Post-Surgical Appalachian Oral Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 42
- Locations
- 2
- Primary Endpoint
- Time to recurrence
Study Overview
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. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Time to recurrence
Time Frame: Up to 5 years
Two side tests and confidence intervals will be constructed using the exact binomial formulation.
Secondary Outcomes
- Adherence rates in patients receiving LBR(Up to 5 years)
- LBR-responsive gene expression before, during, and after LBR administration (Arm I)(Up to 5 years)
- LBR-responsive gene expression in patients not exposed to LBR (Arm II)(Up to 5 years)
- LBR responsive gene activity and time to recurrence(Up to 5 years)
Investigators
Amit Agrawal
Principal Investigator
Ohio State University Comprehensive Cancer Center