Vitamin D Levels in Stage IV Colorectal Cancer Patients

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find out what effects, good and/or bad, vitamin D blood levels has on stage IV colorectal cancer. Tbe doctors want to see if it is possible to increase low vitamin D levels into normal range using vitamin D supplements taken by mouth. Low vitamin D levels have been associated with worse outcomes in persons who have cancer. Low vitamin D may also cause people to have symptoms such as pain and fatigue. We want to see if increasing low vitamin D levels will help improve cancer outcomes. Vitamin D is routinely repleted in all subjects known to be vitamin D deficient. Therefore, the treatment given would be considered standard of care.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

Criteria

Inclusion Criteria:

• Patients with Stage IV (metastatic) colorectal cancer

• Baseline 25-hydroxy vitamin D level < 30 ng/ml

• Age ≥18 years of age

Exclusion Criteria:

• Current or previous malignancy except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years

• Albumin < 3.2

• Patients on concurrent chronic steroids, other than those allowed for routine antiemetics, or inhaled steroids

• Patients receiving phenobarbital, phenytoin, orlistat and cholestyramine

• Hypercalcemia (Calcium >10.5 mg/dl)

• Calcium x Phosphorus > 70 mg2/dL2