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| Name | Class |
|---|---|
| Lotte & John Hecht Memorial Foundation | OTHER |
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The purpose of this study is to investigate the therapeutic effect and the safety of high-dose vitamin D supplementation in metastatic colorectal cancer patients. We propose to supplement metastatic (stage 4) colorectal cancer patients with oral doses of vitamin D to raise serum 25-hydroxy-vitamin D [25(OH)D] levels to the high normal range of 200-250 nmol/L. The primary objective of this study is to evaluate the metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer. The secondary objective is to evaluate patient survival with regards to high-dose vitamin D supplementation.
Hypothesis:
Whereas low doses of vitamin D reportedly play a significant role in prevention of colorectal cancers, do much larger (pharmacological) doses of vitamin D have a significant therapeutic effect against the same kind of cancer?
Metastatic (stage 4) colorectal cancer patients who were randomly assigned to the treatment arm of this study will be orally supplemented with high doses of vitamin D to achieve serum 25(OH)D concentrations of 200-250 nmol/L (80-100 ng/ml). Therefore, the supplementation dosage is not pre-set but will be determined on an individual basis. Vitamin D supplementation will be continued for 16 months, followed by a 12 month follow up period. Monthly monitoring of serum 25(OH)D and calcium levels will assure the safety of our treatment protocol. Subjects in the control arm of the study will be receiving standard cancer care at InspireHealth that includes supplementation with at least 2,000 International Units of vitamin D.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Dietary Supplement (e.g., vitamins, minerals) | Experimental | Experimental arm is supplemented with high-dose of vitamin D. |
|
| No Intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Drug | We propose to study high-dose, oral vitamin D supplementation, raising serum 25-hydroxy-vitamin D (25(OH)D) concentrations to 200 -250 nmol/L, in metastatic colorectal cancer patients with safety, tolerability and survival as the main outcome measurements. The dose is not pre-set and will depend on the individual subjects' serum 25(OH)D concentration. Subjects will be supplemented for 16 months with a daily oral dose, followed by a 12 months follow-up period. |
| Measure | Description | Time Frame |
|---|---|---|
| The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer. | After 16 months of intervention | |
| The metabolic consequences, including tolerability and toxicity, of prolonged, high-dose physiological vitamin D in patients with colorectal cancer. | After 12 months of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Patient survival with regards to high-dose vitamin D supplementation. | After 16 months of intervention | |
| Patient survival with regards to high-dose vitamin D supplementation. | After 12 months of follow-up |
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Inclusion Criteria (We will recruit stage 4 (metastatic) colorectal cancer patients who are clients at InspireHealth):
Exclusion Criteria(Stage 4 colorectal cancer patients):
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| Name | Affiliation | Role |
|---|---|---|
| Hal Gunn, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InspireHealth | Vancouver | British Columbia | V6H 4A6 | Canada |
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| Label | URL |
|---|---|
| Related Info | View source |
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| 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 |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |