Colorectal Cancer
Conditions
Keywords
Vitamin D, Vitamin D3, colon cancer, rectum cancer, Cholecalciferol, 09-143
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.
Interventions
DRUGvitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with Stage IV (metastatic) colorectal cancer * Baseline 25-hydroxy vitamin D level \< 30 ng/ml * Age ≥18 years of age
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not Treated | 12 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 37 / 54 |
| serious Total, serious adverse events | 13 / 54 |
Outcome results
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
Time frame: Within 6 weeks of beginning vitamin D
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | To Achieve Target Vitamin D Level | 41 participants |