Effects of High Dose Calcitriol in Breast Cancer Patients
This study is ongoing, but not recruiting participants.
Sponsor:
University of Rochester
Information provided by (Responsible Party):
Luke Peppone, University of Rochester
ClinicalTrials.gov Identifier:
NCT01293682
First received: February 9, 2011
Last updated: February 5, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: Calcitriol |
Phase 2 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Calcitriol
U.S. FDA Resources
Further study details as provided by University of Rochester:
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.
| Estimated Enrollment: | 25 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Calcitriol |
Drug: Calcitriol
In pill form, 45 micrograms once a week for 12 weeks
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 88 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293682
Locations
| United States, New York | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
Sponsors and Collaborators
University of Rochester
Investigators
| Principal Investigator: | Luke J Peppone, PhD | University of Rochester |
More Information
No publications provided
| Responsible Party: | Luke Peppone, Assistant Professor, University of Rochester |
| ClinicalTrials.gov Identifier: | NCT01293682 History of Changes |
| Other Study ID Numbers: | 25741 |
| Study First Received: | February 9, 2011 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Calcitriol Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013