Spots Global Cancer Trial Database for Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer
Official Title: 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
Study ID: NCT00064298
Conditions
Study Description
Brief Summary: RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Fruit and vegetable extracts may be effective in preventing the recurrence or further development of head and neck cancer. PURPOSE: This randomized phase II trial is studying how well fruit and vegetable extracts work in preventing the recurrence of stage I, stage II, stage III, stage IVA, or stage IVB head and neck cancer.
Detailed Description: OBJECTIVES: * 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 extracts. * 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 treatment arms. * 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CCOP - Santa Rosa Memorial Hospital, Santa Rosa, California, United States
Redwood Regional Medical Group, Santa Rosa, California, United States
CCOP - Christiana Care Health Services, Newark, Delaware, United States
MBCCOP - Howard University Cancer Center, Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
University of Miami Sylvester Comprehensive Cancer Center - Miami, Miami, Florida, United States
MBCCOP - JHS Hospital of Cook County, Chicago, Illinois, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Cedar Rapids Oncology Associates, Cedar Rapids, Iowa, United States
MBCCOP - LSU Health Sciences Center, New Orleans, Louisiana, United States
Feist-Weiller Cancer Center at Louisiana State University Health Sciences, Shreveport, Louisiana, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan, United States
CCOP - Beaumont, Royal Oak, Michigan, United States
CCOP - Metro-Minnesota, Saint Louis Park, Minnesota, United States
Missouri Baptist Cancer Center, Saint Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau, Saint Louis, Missouri, United States
CCOP - Cancer Research for the Ozarks, Springfield, Missouri, United States
Alamance Cancer Center at Alamance Regional Medical Center, Burlington, North Carolina, United States
Hugh Chatham Memorial Hospital, Elkin, North Carolina, United States
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School, Greenville, North Carolina, United States
High Point Regional Hospital, High Point, North Carolina, United States
Caldwell Memorial Hospital, Lenoir, North Carolina, United States
Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
Danville Regional Medical Center, Danville, Virginia, United States
Contact Details
Name: Steven A. Akman, MD
Affiliation: Wake Forest University Health Sciences
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
