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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02603757.
PRIMARY OBJECTIVE:
I. Evaluate the efficacy of D vitamin (vitamin D) supplementation in raising vitamin D levels during chemotherapy for patients with stage III colon and stage II/III rectal cancer to a standard healthy level.
SECONDARY OBJECTIVE:
I. Evaluate the efficacy of vitamin D in improving survival outcomes for patients with Stage III colon and stage II/III rectal cancer.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP A: Beginning same day as chemotherapy treatment, participants receive standard dose of D vitamin orally (PO) daily for 1 year.
GROUP B: Beginning same day as chemotherapy treatment, participants receive high dose of D vitamin PO weekly for 1 year.
After completion of study, participants are followed up every 6 months for up to 5 years.
Lead OrganizationLegacy Good Samaritan Hospital and Medical Center
Principal InvestigatorEric C. Anderson
