A Phase II Randomized Placebo Controlled, Double Blinded Trial To Evaluate The Effects Of Fruit And Vegetable Extracts On Intermediate Biomarkers In Head And Neck Cancer Patients
- Compare the disease-free survival of patients with stage I-IV (including stage IVA and
IVB) head and neck cancer treated with fruit and vegetable extracts vs placebo.
- Compare the effect of these extracts on biomarkers (p27 expression, cell proliferation
of Ki-67, DNA damage, and T-cell function) in these patients.
- Correlate changes in biomarkers with other factors (e.g., site and stage of the
original tumors, tobacco/alcohol use, or depression) in patients treated with these
- Compare serum carotenoids and antioxidant levels (vitamins A, C, and E) at baseline and
posttreatment in patients treated with these extracts.
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are
stratified according to tobacco use (yes vs no), alcohol consumption (yes vs no), and tumor
stage at diagnosis (I vs II vs III vs IVA vs IVB). Patients are randomized to 1 of 2
- Arm I: Patients receive oral fruit and vegetable extracts twice daily.
- Arm II: Patients receive oral placebo twice daily. Treatment in both arms continues for
12 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 200 patients (100 per treatment arm) will be accrued for this
study within 18 months.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Expression of p27 cell cycle regulatory protein, associated with disease-free survival as measured by blood sample at baseline and week 12
baseline and 12 weeks
Steven A. Akman, MD
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Christiana Care Health Services||Wilmington, Delaware 19899|
|CCOP - Mount Sinai Medical Center||Miami Beach, Florida 33140|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|Cedar Rapids Oncology Associates||Cedar Rapids, Iowa 52403|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|CCOP - Santa Rosa Memorial Hospital||Santa Rosa, California 95403|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Cancer Research for the Ozarks||Springfield, Missouri 65807|
|CCOP - Greenville||Greenville, South Carolina 29615|
|CCOP - Northern Indiana CR Consortium||South Bend, Indiana 46601|
|MBCCOP - LSU Health Sciences Center||New Orleans, Louisiana 70112|
|CCOP - St. Louis-Cape Girardeau||Saint Louis, Missouri 63141|
|CCOP - Beaumont||Royal Oak, Michigan 48073-6769|
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|
|MBCCOP - Howard University Cancer Center||Washington, District of Columbia 20060|
|Feist-Weiller Cancer Center at Louisiana State University Health Sciences||Shreveport, Louisiana 71130-3932|
|Danville Regional Medical Center||Danville, Virginia 24541|
|Missouri Baptist Cancer Center||St. Louis, Missouri 63131|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|
|Leo W. Jenkins Cancer Center at ECU Medical School||Greenville, North Carolina 27834|
|High Point Regional Hospital||High Point, North Carolina 27261|
|Alamance Cancer Center at Alamance Regional Medical Center||Burlington, North Carolina 27216|
|Redwood Regional Medical Group||Santa Rosa, California 95403|
|MBCCOP - JHS Hospital of Cook County||Chicago, Illinois 60612|
|Hugh Chatham Memorial Hospital||Elkin, North Carolina 28621|
|Caldwell Memorial Hospital||Lenoir, North Carolina 28645|