CompletedPhase 4

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.

Egypt44 participantsStarted 2024-07-31

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The change in the serum concentrations of the measured biological markers

Timeframe: 6 months

Trial details

NCT IDNCT07241247

SponsorTanta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-10

View on ClinicalTrials.gov More Vitamin D on Tumor Response and Inflammatory Markers trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.