Effects of High Dose Calcitriol in Breast Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Luke Peppone, University of Rochester
ClinicalTrials.gov Identifier:
NCT01293682
First received: February 9, 2011
Last updated: July 31, 2014
Last verified: July 2014

February 9, 2011
July 31, 2014
November 2010
April 2015   (final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01293682 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effects of High Dose Calcitriol in Breast Cancer Patients
A Pilot Study of the Effects of High-Dose Oral Calcitriol in Breast Cancer Patients Prior to Surgery

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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Breast Cancer
Drug: Calcitriol
In pill form, 45 micrograms once a week for 12 weeks
Active Comparator: Calcitriol
Intervention: Drug: Calcitriol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
Not Provided
April 2015   (final data collection date for primary outcome measure)

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.
Female
18 Years to 88 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01293682
25741
Yes
Luke Peppone, University of Rochester
University of Rochester
Not Provided
Principal Investigator: Luke J Peppone, PhD University of Rochester
University of Rochester
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP