Food-Based Modulation of Biomarkers in Human Tissues at High-Risk for Oral Cancer
I. Determine the adherence of post-surgical head and neck (HN) cancer patients to clinical
trial design expectations and define tolerability and potential adverse effects of long-term
black raspberry administration in this patient cohort.
II. Determine the effects of dose and delivery vehicle on the degree of uptake of black
raspberry components in target oral tissues of post-surgical HN cancer patients over time
and determine the relationships between adherence/exposure data and uptake.
III. Determine the ability of black raspberries to modulate patterns of gene expression
within key regulatory pathways in "at-risk normal" oral mucosa of post-surgical HN cancer
patients that would favor the inhibition, delay or reversal of oral carcinogenesis.
IV. Determine the persistence of modulation of "berry-responsive genes" for 2 years
following commencement of black raspberry treatment and preliminarily define rate of
recurrence and second primary oral cancers in a former oral cancer patient sub-cohort.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive lozenge placebo orally (PO) four times daily (QID).
ARM II: Patients receive lyophilized black raspberries lozenge PO QID.
ARM III: Patients receive Saliva Substitute placebo PO QID.
ARM IV: Patients receive lyophilized black raspberries Saliva Substitute PO QID.
In all arms, treatment continues for 6 months. Oral cavity scrapings, blood, urine, and
saliva samples are collected periodically for laboratory analyses.
After completion of study treatment, some patients are followed up at weeks 1-5 and then at
2, 6, 12, and 18 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Define tolerability and potential adverse effects of long-term black raspberry administration of post-surgical HN cancer patients
up to 2 years
Ohio State University
United States: Institutional Review Board
|Ohio State University Medical Center||Columbus, Ohio 43210|