- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00905918
Vitamin E Supplements in Treating Patients Undergoing Surgery for Colorectal Cancer
A Randomized Study to Investigate the Presence of Tocopherol Metabolites in the Colon
RATIONALE: Vitamin E may help prevent the development of cancer. Studying samples of tissue from patients with colorectal cancer who receive Vitamin E before undergoing surgery in the laboratory may help doctors learn more about how Vitamin E changes biomarkers related to colorectal cancer.
PURPOSE: This randomized early phase I trial is studying giving vitamin E supplements to see how it affects biomarkers in patients undergoing surgery for colorectal cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- Determine the effect of high γ-tocopherol vitamin E mixture supplementation on plasma levels of α-, γ-, and δ-tocopherols, and prostaglandin E_2 in patients planning to undergo surgery for colorectal cancer by comparing the blood samples collected before and after the supplementation in each of the groups and analyzing levels of tocopherols and their metabolites in urine samples.
- Test the hypothesis that the supplementation reduces oxidative and nitrosative stress by measuring plasma levels of F_2-isoprostane, C-reactive protein, and 3-nitrotyrosine as well as urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG).
- Determine the levels of α-, γ-, and δ-tocopherols in colon tissues and analyze immunohistochemically for cell proliferation, apoptosis, β-catenin localization, RXR expression, cyclooxygenase-2, 8-OHdG, and 3-nitrotyrosine levels in colon cancer tissue slides.
OUTLINE: This is a multicenter study. The first 5 patients receive no supplements (to establish laboratory standards), all other patients are randomized to 1 of 3 treatment arms.
- Arm I: Patients receive no intervention before undergoing planned surgery.
- Arm II: Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 1 week before undergoing planned surgery.
- Arm III: Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 2 weeks before undergoing planned surgery.
Blood and urine samples are collected at baseline and on the day of surgery for tocopherol and biomarker analysis. A sample of colon tissue is removed during standard surgical resection for chemical analysis. Plasma, tumor tissue, and nontumorous tissues are analyzed for levels of F_2-isoprostane, 8-OHdG, 3-nitrotyrosine, and prostaglandin E_2 via enzyme immunoassays and for levels of α-, γ-, and δ-tocopherols via HPLC.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 1
Kontakter och platser
Studieorter
-
-
New Jersey
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New Brunswick, New Jersey, Förenta staterna, 08903
- Rutgers Cancer Institute of New Jersey
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Suspected or confirmed colorectal cancer meeting the following criteria:
- Scheduled for surgery as the initial treatment
- Referred to the Cancer Institute of New Jersey or the Robert Wood Johnson University Hospital
- No requirement for urgent surgery (i.e., surgery that cannot wait for 2 weeks)
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Patients deemed in adequate health to undergo colon resection by their surgeon
- No uncontrolled diabetes, uncontrolled BP, chronic congestive heart failure, or history of renal insufficiency
- No personal or family history of bleeding disorders
- No known history of problems absorbing fats (e.g., Crohn disease, cystic fibrosis)
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy for the treatment of this cancer
- More than 2 weeks since prior NSAIDs or corticosteroids
- No concurrent colestipol or orlistat
- No concurrent warfarin or dicumarol
No concurrent supplementation of vitamin E
- A multivitamin containing ≤ 60 IU vitamin E allowed
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Arm I
Patients receive no intervention before undergoing planned surgery.
|
|
Experimentell: Arm II
Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 1 week before undergoing planned surgery.
|
Ges oralt
All patients undergo biomarker analyses
|
Experimentell: Arm III
Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 2 weeks before undergoing planned surgery.
|
Ges oralt
All patients undergo biomarker analyses
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Plasma and urine levels of α-, γ-, and δ-tocopherols, and prostaglandin E2
Tidsram: 4 years
|
4 years
|
Plasma levels of F2-isoprostane, C-reactive protein, and 3-nitrotyrosine and urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG)
Tidsram: 4 years
|
4 years
|
Presence in colon tissue of α-, γ-, and δ-tocopherols, cell proliferation and apoptosis indicators, β-catenin localization, RXR expression, and cyclooxygenase-2, 8-OHdG, and 3-nitrotyrosine levels
Tidsram: 4 years
|
4 years
|
Samarbetspartners och utredare
Utredare
- Huvudutredare: Susan Goodin, PharmD, FCCP, BCOP, Rutgers Cancer Institute of New Jersey
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Kolonsjukdomar
- Tarmsjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Kolorektala neoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Skyddsmedel
- Mikronäringsämnen
- Vitaminer
- Antioxidanter
- Vitamin E
Andra studie-ID-nummer
- 120901
- P30CA072720 (U.S.S. NIH-anslag/kontrakt)
- CDR0000642446 (Annan identifierare: NIH)
- 0220090065 (Annan identifierare: IRB)
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-
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