RecruitingEarly Phase 1NCT02172651

Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases

Study to Identify Transcriptional Targets of Vitamin D in Patients With Stage I-III Colon Cancer or Resectable Colon Cancer Liver Metastases Receiving Preoperative Vitamin D Supplementation.

Sponsor

Dana-Farber Cancer Institute

Enrollment

80 participants

Start Date

Jul 14, 2014

Study Type

INTERVENTIONAL

Conditions

Stage, Colon Cancer Stage I-III Colon Cancer Stage IV Colon Cancer With Resectable Liver Metastases

Summary

This study seeks to learn more about the vitamin D receptor and its relationship to colon cancer. The Vitamin D receptor is found in colon cancer cells. When Vitamin D binds to the receptor in the cancer cells, it may stop cancer cells from growing abnormally and may cause cancer cell death. Vitamin D has been used in other research studies and information from those other research studies suggests that Vitamin D may help in the treatment of colon cancer. Participants will receive either high-dose vitamin D or standard-dose vitamin D. The study drug will be given 14-28 days prior to your surgery. The number of days will depend on when the surgery is scheduled.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether taking vitamin D supplements after surgery for early to mid-stage colon cancer (stages I–III) can reduce the risk of the cancer coming back or improve survival outcomes. **You may be eligible if...** - You have been diagnosed with stage I, II, or III colon cancer (cancer that has not spread to distant organs) - You are having surgery to remove the colon cancer — OR you have colon cancer with liver metastases that can be surgically removed - You are 18 or older with good overall health and organ function - You have an ECOG performance status of 0 or 1 (able to carry out normal activities) **You may NOT be eligible if...** - You have already received chemotherapy or radiation for stage I–III colon cancer before surgery - Your calcium levels are elevated above normal - Your organ function (liver, kidneys) does not meet the minimum requirements - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVitamin D3

Take five 10,000 IU capsules (total 50,000 IU) once daily for 7 days, followed by one 10,000 IU capsule once daily until surgery.

DRUGPlacebo

Take five placebo capsules once daily for 7 days, followed by one placebo capsule once daily until surgery.

Locations(1)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

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NCT02172651