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The aim of this work is to assess the of role of Vitamin D supplement on tumor response, inflammation and apoptosis in patients with stage II or III colorectal cancer receiving chemotherapy using BAX protein and Tumor necrosis factor - alpha (TNF- α) both are measured at baseline and after 6 months.
This randomized, controlled parallel study will be conducted on 44 patients with Stage II or III colorectal cancer. Patients will be recruited from Clinical Oncology
Department, Menoufia university Hospital, Menoufia, Egypt. The patients will be randomized using sealed envelope method into the following two groups:
Group I (Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin).
Group II: (Vitamin D group; n=22) which will receive the same chemotherapy regimen plus Vitamin D for 6 months.
Markers to be measured:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D group | Experimental | (Vitamin D group; n=22) which will receive the same chemotherapy regimen plus Vitamin D for 6 months. |
|
| Control group | No Intervention | (Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | Vitamin D supplement has effect on tumor response, inflammation and apoptosis |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in the serum concentrations of the measured biological markers |
| 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menofia university | Cairo | Egypt |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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