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.

NCT ID: NCT07241247

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2025-10-10

Brief Summary

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.

Detailed Description

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:

• BAX protein as a marker for apoptosis will be measured at baseline and after 6 months.
• Tumor necrosis factor - alpha (TNF- α) as a marker of inflammation will be measured at baseline and after 6 months.

Conditions

Vitamin D on Tumor Response and Inflammatory Markers; Colo-rectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D group

(Vitamin D group; n=22) which will receive the same chemotherapy regimen plus Vitamin D for 6 months.

Group Type: EXPERIMENTAL

Vitamin D

Intervention Type: DRUG

Vitamin D supplement has effect on tumor response, inflammation and apoptosis

Control group

(Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin D

Vitamin D supplement has effect on tumor response, inflammation and apoptosis

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Menna Allah Ayman Aboelenean

Clinical pharmacist, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Menofia university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

4/2024ONCO15

Identifier Type: -

Identifier Source: org_study_id