Vitamin D Levels in Stage IV Colorectal Cancer Patients
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2010 |
| End Date: | October 2014 |
Vitamin D Levels in Stage IV Colorectal Cancer Patients: A Phase II Study
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.
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.
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
We found this trial at
5
sites
1000 N Village Ave
Rockville Centre, New York 11570
Rockville Centre, New York 11570
(516) 256-3600
Memorial Sloan-Kettering at Mercy Medical Center Memorial Sloan Kettering Cancer Center Rockville Centre provides state-of-the-art...
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