Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D, vitamin D3 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Wesa, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memoral Sloan Kettering Cancer Center | Basking Ridge | New Jersey | United States | |||
| Memorial Sloan-Kettering Cancer Center @ Suffolk |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Patients | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Patients | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Number | participants | Within 6 weeks of beginning vitamin D |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Patients | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | CTC-4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | CTC-4.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barrie Cassileth | Memorial Sloan Kettering Cancer Center | 646-888-0801 | Cassileth@mskcc.org |
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 13 |
| 54 |
| 37 |
| 54 |
| Allergic reaction | General disorders | CTC-4.0 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
|
| Anorexia | General disorders | CTC-4.0 | Systematic Assessment |
|
| Cardiac arrest | Cardiac disorders | CTC-4.0 | Systematic Assessment |
|
| Catheter related infection | Infections and infestations | CTC-4.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | Systematic Assessment |
|
| Death NOS | General disorders | CTC-4.0 | Systematic Assessment |
|
| Dehydration | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTC-4.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTC-4.0 | Systematic Assessment |
|
| Febrile neutropenia | General disorders | CTC-4.0 | Systematic Assessment |
|
| Fever | General disorders | CTC-4.0 | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTC-4.0 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Hypotension | Cardiac disorders | CTC-4.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | CTC-4.0 | Systematic Assessment |
|
| Lung infection | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
|
| Obstruction gastric | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
|
| Pain | General disorders | CTC-4.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTC-4.0 | Systematic Assessment |
|
| Prostate infection | Infections and infestations | CTC-4.0 | Systematic Assessment |
|
| Renal and urinary disorders | Renal and urinary disorders | CTC-4.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
|
| Surgical and medical procedures - Other | General disorders | CTC-4.0 | Systematic Assessment |
|
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | CTC-4.0 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | CTC-4.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Alkaline phosphatase increased | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Anorexia | General disorders | CTC-4.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | CTC-4.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Blood bilirubin increased | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTC-4.0 | Systematic Assessment |
|
| Fatigue | General disorders | CTC-4.0 | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTC-4.0 | Systematic Assessment |
|
| Prothrombin ratio and international normalized ratio increased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
|
| Lymphocyte count decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
|
| Mucositis oral | General disorders | CTC-4.0 | Systematic Assessment |
|
| Neutrophil count decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
|
| Pain | General disorders | CTC-4.0 | Systematic Assessment |
|
| Pain in extremity | General disorders | CTC-4.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTC-4.0 | Systematic Assessment |
|
| Platelet count decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
|
| Surgical and medical procedures - Other | General disorders | CTC-4.0 | Systematic Assessment |
|
| White blood cell decreased | Blood and lymphatic system disorders | CTC-4.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |