D Vitamin in Treating Participants with Stage III Colon Cancer or Stage II / III Rectal Cancer
This pilot trial studies how well D vitamin works in treating participants with stage III colon cancer or stage II / III rectal cancer. D vitamin may raise serum vitamin D levels and impact survival of colon and rectal cancer patients.
- 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 total 25-hydroxy level below 66 ng/ml
- 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 a Legacy Health/Oregon Health & Science University (OHSU) facility if necessary
- Agree to attend study visits outside of standard of care visits, if needed
- Colon cancer stages I-II and IV or rectal cancer stage I or IV
- Multi-focal disease (unless pre-approved by principal investigator [PI])
- 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
- 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 total 25-hydroxy level above 66 ng/ml at baseline testing
- Patients with hypercalcemia and/or any condition resulting in malabsorption
- Unable to comply with protocol
- Unable to provide written informed consent
- Investigator does not believe study participation, for any reason, is in the best interest of the patient
Locations & Contacts
Contact: Eric C. Anderson
Trial Objectives and Outline
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.
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 year for up to 5 years.
Trial Phase & Type
Legacy Good Samaritan Hospital and Medical Center
Eric C. Anderson
Secondary IDs NCI-2018-00493
Clinicaltrials.gov ID NCT02603757