Effects of High Dose Calcitriol in Breast Cancer Patients
This study has been completed.
Information provided by (Responsible Party):
Luke Peppone, University of Rochester
First received: February 9, 2011
Last updated: June 3, 2015
Last verified: June 2015
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.
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
||A Pilot Study of the Effects of High-Dose Oral Calcitriol in Breast Cancer Patients Prior to Surgery
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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:
| Study Completion Date:
| 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.
|Ages Eligible for Study:
||18 Years to 88 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Must be female.
- Must have pathologically confirmed incident, primary invasive breast cancer.
- Must be awaiting surgical resection.
- Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods (abstinence, intrauterine device (IUD), or double barrier device) and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Contraceptive use needs to be continued at least 1 month after the trial has ended.
- Must provide informed consent.
- Must be willing to discontinue use of calcium and/or vitamin D supplements other than multivitamin supplementation.
- Participants must have an ionized serum calcium level within normal limits (1.19-1.29mmol/L) and a total corrected serum calcium of < 10.2mg/dl.
- Subjects with life-threatening conditions that would preclude them from breast cancer treatment including: chronic cardiac failure, which is unstable despite medication use; uncontrolled hypertension; uncontrolled diabetes mellitus; or unstable coronary artery disease.
- Patients with severe metabolic disorders, which includes phenylketonuria (PKU), homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.
- Patients with a previous history of any other cancer except non-melanomous skin cancer within the past 5 years.
- Patients with impaired renal function (CRCL < 60 mL/min) or who had kidney stones (calcium salt) within the past 5 years.
- Patients with hypercalcemia (corrected serum CA > 10.2 mg/dl) or a history of hypercalcemia or vitamin D toxicity.
- Patients currently taking calcium supplements or aluminum-based antacids must immediately discontinue their use if they are to enroll in the study.
- Patients currently taking vitamin D supplements must immediately discontinue their use if they are to enroll in the study.
- Patients with a known sensitivity to calcitriol.
- Women who are pregnant or lactating.
- Women on antiresorptive drugs (e.g. bisphosphonates) within the past year.
- Women currently using oral contraception.
- Women with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran).
- Participants assigned to calcitriol who are routinely taking a multivitamin supplement may continue the supplement as long as the amount of vitamin D in the supplement is not in excess of the RDA (recommended daily allowance) of 400 IU or 10 μg. If they are not taking a multivitamin supplement, they will be asked to not start supplementation while on study.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01293682
|University of Rochester
|Rochester, New York, United States, 14642 |
University of Rochester
||Luke J Peppone, PhD
||University of Rochester
||Luke Peppone, Assistant Professor, University of Rochester
History of Changes
|Other Study ID Numbers:
|Study First Received:
||February 9, 2011
||June 3, 2015
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 27, 2016
Neoplasms by Site
Bone Density Conservation Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs