Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT02603757
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02603757
Study Brief:
Protocol Section:
NCT02603757