Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064298
Status:
COMPLETED
Last Update Posted:
2021-09-28
First Post:
2003-07-08
Brief Title:
Fruit and Vegetable Extracts in Treating Patients With Stage I-IV Stage IVAIVB Head and Neck Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg site and stage of the original tumors tobaccoalcohol 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
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 eg site and stage of the original tumors tobaccoalcohol 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA081851 | NIH | None | httpsreporternihgovquickSearchU10CA081851 |