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.

NCT07241247 | Completed Phase 4

• 1 other identifier: 4/2024ONCO15
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• The change in the serum concentrations of the measured biological markers

  * BAX protein as a marker for apoptosis * Tumor necrosis factor - alpha (TNF- α) as a marker of inflammation

  6 months

Study Arms (2)

Vitamin D group

EXPERIMENTAL

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

Drug: Vitamin D

Control group

NO INTERVENTION

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

Interventions

Vitamin D DRUG

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

Vitamin D group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Menofia university

Cairo, Egypt

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical pharmacist, principal investigator

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 21, 2025
• Study Start: July 31, 2024
• Primary Completion: June 10, 2025
• Study Completion: October 10, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Locations

EG (1)