Vitamin D Levels in Stage IV Colorectal Cancer Patients
1 other identifier
interventional
45
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 colorectal-cancer
Started Feb 2010
Typical duration for phase_2 colorectal-cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 22, 2010
CompletedFirst Posted
Study publicly available on registry
February 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedResults Posted
Study results publicly available
February 3, 2016
CompletedFebruary 3, 2016
January 1, 2016
4.7 years
February 22, 2010
January 4, 2016
January 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To Achieve Target Vitamin D Level
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
Within 6 weeks of beginning vitamin D
Study Arms (1)
vitamin D, vitamin D3
EXPERIMENTALThis 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.
Interventions
Patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
Eligibility Criteria
You may qualify if:
- Patients with Stage IV (metastatic) colorectal cancer
- Baseline 25-hydroxy vitamin D level \< 30 ng/ml
- Age ≥18 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan-Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Memorial Sloan-Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital
Sleepy Hollow, New York, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Barrie Cassileth
- Organization
- Memorial Sloan Kettering Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen Wesa, MD
Memorial Sloan Kettering Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2010
First Posted
February 24, 2010
Study Start
February 1, 2010
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
February 3, 2016
Results First Posted
February 3, 2016
Record last verified: 2016-01