Vitamin D Levels in Stage IV Colorectal Cancer Patients

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)

• Registration Number: NCT01074216
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-22
• Study First Posted: 2010-02-24
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2016-01
• Results First Submitted: 2016-01-04
• Results First Submitted QC: 2016-01-04
• Last Update Submitted: 2016-01-04
• Results First Posted: 2016-02-03
• Last Update Posted: 2016-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Patients with Stage IV (metastatic) colorectal cancer
• Baseline 25-hydroxy vitamin D level < 30 ng/ml
• Age ≥18 years of age

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
vitamin D, vitamin D3	vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)	This is a Phase II study involving Stage IV colorectal cancer patients with serum vitamin D deficiency, to determine the ability to correct vitamin D deficiency and to maintain serum vitamin D levels (25-hydroxy vitamin D) once achieved.

Primary Outcome Measures

Name	Time	Method
To Achieve Target Vitamin D Level	Within 6 weeks of beginning vitamin D	To determine the ability of achieving the target serum 25-hydroxy vitamin D level of 40 ng/ml within 6 weeks of beginning vitamin D supplements in patients with metastatic colon cancer. A response is defined as achieving serum vitamin D levels ≥40 ng/ml at least once at any point during the first 6 weeks

Trial Locations

Locations (5)

Memoral Sloan Kettering Cancer Center; 🇺🇸 Basking Ridge, New Jersey, United States

Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital; 🇺🇸 Sleepy Hollow, New York, United States

Memorial Sloan-Kettering at Mercy Medical Center; 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan-Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States