Clinical trial · Interventional
Evaluation the of Role of Vitamin D Supplement on Tumor Response, Inflammation and Apoptosis in Patients With Stage II or III Colorectal Cancer Receiving Chemotherapy.
Clinical Study Evaluating the Role of Vitamin D Supplement in Patients With Colorectal Cancer Receiving Chemotherapy
NCT07241247CI-TRIAL-00097740completedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colo-rectal Cancer | — | UNRESOLVED | — |
| Vitamin D on Tumor Response and Inflammatory Markers | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin D | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin D group
- description
- (Vitamin D group; n=22) which will receive the same chemotherapy regimen plus Vitamin D for 6 months.
- interventionNames
- Drug: Vitamin D
- type
- NO_INTERVENTION
- label
- Control group
- description
- (Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin).
Primary outcomes (1)
- measure
- The change in the serum concentrations of the measured biological markers
- timeFrame
- 6 months
- description
- * BAX protein as a marker for apoptosis * Tumor necrosis factor - alpha (TNF- α) as a marker of inflammation
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically and radiologically confirmed diagnosis of stage II or III colorectal cancer. * Performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG). * Patients who received FOLFOX or XELOX as first line chemotherapy. * Both genders. * Age ≥18. * Patients with adequate hematologic parameters (white blood cell count ≥3000/mm3, granulocytes ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥ 8 gm/l). * Patients with normal renal functions. * Patients with normal hepatic functions. * Patients with sufficient 25(OH) Vitamin D level (30-100 ng/mL). Exclusion Criteria: * Patients with metastatic colorectal cancer (CRC). * Patients with parathyroid disorders. * Patients who are taking vitamin D-containing supplements (\>800 IU/day) unless they discontinued vitamin D supplementation at least 2 months prior to enrollment. * Patients had a history of hypercalcemia.
References
Publications (0)
Data not yet available
No reference posted for this study.