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Trial record 70 of 127 for:    colon cancer AND Rectal | ( Map: New Jersey, United States )

Vitamin D Levels in Stage IV Colorectal Cancer Patients

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ClinicalTrials.gov Identifier: NCT01074216
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Colorectal Cancer
Intervention Drug: vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title All Patients
Hide Arm/Group Description Stage IV colorectal cancer 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.
Period Title: Overall Study
Started 54
Completed 41
Not Completed 13
Reason Not Completed
Physician Decision             1
Not Treated             12
Arm/Group Title All Patients
Hide Arm/Group Description Stage IV colorectal cancer 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.
Overall Number of Baseline Participants 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
<=18 years
0
   0.0%
Between 18 and 65 years
38
  70.4%
>=65 years
16
  29.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants
Female
22
  40.7%
Male
32
  59.3%
1.Primary Outcome
Title To Achieve Target Vitamin D Level
Hide Description 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
Time Frame Within 6 weeks of beginning vitamin D
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title All Patients
Hide Arm/Group Description:
Stage IV colorectal cancer 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.
Overall Number of Participants Analyzed 41
Measure Type: Number
Unit of Measure: participants
41
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description Stage IV colorectal cancer 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.
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients
Affected / at Risk (%) # Events
Total   13/54 (24.07%)    
Blood and lymphatic system disorders   
Anemia  1  2/54 (3.70%)  2
Cardiac disorders   
Cardiac arrest  1  1/54 (1.85%)  1
Hypotension  1  1/54 (1.85%)  1
Gastrointestinal disorders   
Dehydration  1  2/54 (3.70%)  2
Diarrhea  1  1/54 (1.85%)  1
Nausea  1  2/54 (3.70%)  2
Obstruction gastric  1  1/54 (1.85%)  1
Small intestinal obstruction  1  1/54 (1.85%)  1
Upper gastrointestinal hemorrhage  1  1/54 (1.85%)  1
Vomiting  1  1/54 (1.85%)  1
General disorders   
Abdominal pain  1  2/54 (3.70%)  2
Allergic reaction  1  1/54 (1.85%)  1
Anorexia  1  1/54 (1.85%)  1
Death NOS  1  2/54 (3.70%)  2
Fatigue  1  1/54 (1.85%)  1
Febrile neutropenia  1  1/54 (1.85%)  2
Fever  1  1/54 (1.85%)  1
Pain  1  1/54 (1.85%)  1
Surgical and medical procedures - Other  1  1/54 (1.85%)  1
Infections and infestations   
Catheter related infection  1  1/54 (1.85%)  1
Infections and infestations  1  1/54 (1.85%)  1
Prostate infection  1  1/54 (1.85%)  1
Metabolism and nutrition disorders   
Hyponatremia  1  1/54 (1.85%)  1
Musculoskeletal and connective tissue disorders   
Generalized muscle weakness  1  1/54 (1.85%)  1
Nervous system disorders   
Dizziness  1  1/54 (1.85%)  2
Renal and urinary disorders   
Renal and urinary disorders  1  1/54 (1.85%)  1
Urinary tract infection  1  2/54 (3.70%)  3
Urinary tract obstruction  1  1/54 (1.85%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/54 (1.85%)  1
Dyspnea  1  2/54 (3.70%)  2
Hypoxia  1  1/54 (1.85%)  1
Lung infection  1  1/54 (1.85%)  1
Pleural effusion  1  1/54 (1.85%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%) # Events
Total   37/54 (68.52%)    
Blood and lymphatic system disorders   
Prothrombin ratio and international normalized ratio increased  1  7/54 (12.96%) 
Lymphocyte count decreased  1  8/54 (14.81%) 
Neutrophil count decreased  1  14/54 (25.93%) 
Platelet count decreased  1  6/54 (11.11%) 
White blood cell decreased  1  14/54 (25.93%) 
Gastrointestinal disorders   
Constipation  1  4/54 (7.41%) 
Diarrhea  1  4/54 (7.41%) 
General disorders   
Abdominal pain  1  8/54 (14.81%) 
Anorexia  1  5/54 (9.26%) 
Fatigue  1  14/54 (25.93%) 
Mucositis oral  1  6/54 (11.11%) 
Pain  1  4/54 (7.41%) 
Pain in extremity  1  3/54 (5.56%) 
Surgical and medical procedures - Other  1  4/54 (7.41%) 
Metabolism and nutrition disorders   
Alanine aminotransferase increased  1  6/54 (11.11%) 
Alkaline phosphatase increased  1  9/54 (16.67%) 
Aspartate aminotransferase increased  1  7/54 (12.96%) 
Blood bilirubin increased  1  8/54 (14.81%) 
Hyperglycemia  1  14/54 (25.93%) 
Hypoalbuminemia  1  8/54 (14.81%) 
Hypocalcemia  1  10/54 (18.52%) 
Hyponatremia  1  4/54 (7.41%) 
Hypophosphatemia  1  9/54 (16.67%) 
Nervous system disorders   
Peripheral sensory neuropathy  1  8/54 (14.81%) 
Psychiatric disorders   
Anxiety  1  3/54 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-4.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Barrie Cassileth
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-0801
EMail: Cassileth@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01074216     History of Changes
Other Study ID Numbers: 09-143
First Submitted: February 22, 2010
First Posted: February 24, 2010
Results First Submitted: January 4, 2016
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016