Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Colorectal Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 10/20/2017 |
| Start Date: | March 2016 |
| End Date: | December 2022 |
| Contact: | Jennifer Stubbs, BS |
| Email: | jstubbs@lhs.org |
| Phone: | 503.413.7202 |
Prospective Pilot Study to Assess the Effectiveness of Vitamin D Supplementation for Patients Requiring Chemotherapy for Stage III Colorectal Cancer
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.
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.
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
We found this trial at
3
sites
Click here to add this to my saved trials
24800 SE Stark St
Gresham, Oregon 97030
Gresham, Oregon 97030
(503) 674-1122
Phone: 503-413-8199
Legacy Mount Hood Medical Center Legacy Mount Hood Medical Center, East County's full-service community hospital,...
Click here to add this to my saved trials
Click here to add this to my saved trials