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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000642446 | Other Identifier | NIH | |
| 0220090065 | Other Identifier | IRB | |
| P30CA072720 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Rutgers Cancer Institute of New Jersey | OTHER |
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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.
OBJECTIVES:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | No Intervention | Patients receive no intervention before undergoing planned surgery. | |
| Arm II | Experimental | Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 1 week before undergoing planned surgery. |
|
| Arm III | Experimental | Patients receive oral high γ-tocopherol vitamin E mixture supplementation once daily for 2 weeks before undergoing planned surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin E | Dietary Supplement | Given orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and urine levels of α-, γ-, and δ-tocopherols, and prostaglandin E2 | 4 years | |
| Plasma levels of F2-isoprostane, C-reactive protein, and 3-nitrotyrosine and urinary levels of 8-hydroxy-2-deoxyguanosine (8-OHdG) | 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 | 4 years |
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DISEASE CHARACTERISTICS:
Suspected or confirmed colorectal cancer meeting the following criteria:
No requirement for urgent surgery (i.e., surgery that cannot wait for 2 weeks)
PATIENT CHARACTERISTICS:
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
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| Name | Affiliation | Role |
|---|---|---|
| Susan Goodin, PharmD, FCCP, BCOP | Rutgers Cancer Institute of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D014810 | Vitamin E |
| ID | Term |
|---|---|
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| laboratory biomarker analysis |
| Other |
All patients undergo biomarker analyses |
|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |