Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer

Study Overview
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Brief Summary
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This is a pilot study to test whether there is an association between baseline Vitamin D levels, Vitamin D supplementation and survival in patients with stage III colon and stage II/III rectal cancer receiving chemotherapy. 70 patients with colon stage III or rectal stage II or III cancer that require chemotherapy will be screened and 60 patients will be enrolled. Patients will be randomized to standard dose (2000 IU daily) or high-dose (50,000 IU weekly) Vitamin D supplementation for 1 year after initiation of chemotherapy. Patients' Vitamin D levels will be checked throughout supplementation then followed for 5 years with occasional Vitamin D testing and surveying in order to collect information on recurrence and survival outcomes.

Official Title
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Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Chemotherapy for Stage III Colorectal Cancer

Conditions
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Colon Cancer, Rectal Cancer

Intervention / Treatment
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* Dietary Supplement: cholecalciferol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Willing to stop herbal medications as directed by physician Willing to stop current supplemental Vitamin D (Multivitamin with Vitamin D component is acceptable) Willing to travel to Legacy Health/OHSU facility if necessary Agree to attend study visits outside of standard of care visits, if necessary Diagnosed with stage III colon or stage II/III rectal cancer that will receive neoadjuvant or adjuvant chemotherapy but have not yet started Baseline serum Vitamin D level below 52 ng/ml Exclusion Criteria: ≤ 18 years of age Colon cancer stages I-II and IV or Rectal cancer stage I or IV Patients who do not undergo chemotherapy Patients with prior chemotherapy for this cancer No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer for which the patient has been disease-free for > 3 years Unable to comply with protocol Unable to provide written informed consent Unwilling or unable to stop oral supplemental Vitamin D Patients taking high-dose Vitamin D supplementation (50,000 IU weekly) prior to enrollment Patients with Vitamin D levels above 52 ng/ml at baseline testing Patients with hypercalcemia and/or any condition resulting in malabsorption Investigator does not believe study participation, for any reason, is in the best interest of the patient

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>Standard-dose of 2,000 IU Vitamin D3, daily | Dietary Supplement: cholecalciferol<br>* 2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily<br>* Other names: Vitamin D3;|
| Experimental: Group B<br>Higher-dose of 50,000 IU of Vitamin D3, weekly | Dietary Supplement: cholecalciferol<br>* 2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily<br>* Other names: Vitamin D3;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in serum Vitamin D3 level during chemotherapy in the active supplementation group compared to the control group. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relapse-free survival (RFS) |  | 5 years | 
| Overall survival (OS) |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D