Colon Cancer Clinical Trial
Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer
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.
Eligibility Criteria
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
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There are 3 Locations for this study
Gresham Oregon, 97030, United States
Portland Oregon, 97210, United States
Tualatin Oregon, 97062, United States
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