Colon Cancer, Rectal Cancer
Conditions
Keywords
Vitamin D
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTcholecalciferol
2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily
Sponsors
Legacy Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in serum Vitamin D3 level during chemotherapy in the active supplementation group compared to the control group. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Relapse-free survival (RFS) | 5 years |
| Overall survival (OS) | 5 years |
Countries
United States
Outcome results
None listed