Effects of High Dose Calcitriol in Breast Cancer Patients
This research will examine the effectiveness of calcitriol in treating bone loss in women who are about to begin treatment for breast cancer. Twenty-five (25) subjects are expected to take part in this study. The investigators don't know if bone loss in breast cancer survivors should be treated differently than bone loss in other women.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Pilot Study of the Effects of High-Dose Oral Calcitriol in Breast Cancer Patients Prior to Surgery|
- efficacy and feasibility of Calcitriol 45 μg [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
To collect data on the efficacy and feasibility of Calcitriol 45 μg for maintaining proper bone health among invasive breast cancer patients for a period of 12 weeks.
To collect preliminary data on the effect of Calcitriol 45 μg on bone resorption, as measured by Cross-Linked N-Telopeptide of Type I collagen (NTx) in invasive breast cancer patients over the course of 12 weeks.
To collect preliminary data on the effect of Calcitriol 45 μg on markers of bone formation, as measured by bone-specific alkaline phosphatase (BAP) in invasive breast cancer patients over the course of 12 weeks.
- preliminary data on the effect of pre-surgical Calcitriol 45 μg therapy on tumor cell apoptosis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To collect preliminary data on the effect of pre-surgical Calcitriol 45 μg therapy on tumor cell apoptosis (caspase 3 and survivin), tumor cell proliferation (Ki-67), tumor invasiveness (ER α, PgR, VDR, EGFR, HER2, VEGF, and IGFR), 1α,25(OH)2D3, and Mammostrat Recurrence Score in invasive breast cancer patients.
|Study Start Date:||November 2010|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Calcitriol
In pill form, 45 micrograms once a week for 12 weeks
Other Name: Rocatrol
The calcitriol intervention is aimed at reducing fracture risk by maintaining proper bone density. Calcitriol is efficacious in maintaining proper bone health and muscle mass among the general population, but little research has been done on breast cancer patients. In addition, calcitriol may be effective in reducing tumor proliferation and angiogenesis, while increasing tumor apoptosis. Each of those factors could have beneficial effects on breast cancer outcomes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293682
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Luke J Peppone, PhD||University of Rochester|