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A Pilot Study of the Effects of High-Dose Oral Calcitriol in Breast Cancer Patients Prior to Surgery


Phase 2
18 Years
88 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Pilot Study of the Effects of High-Dose Oral Calcitriol in Breast Cancer Patients Prior to Surgery


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.


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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

efficacy and feasibility of Calcitriol 45 μg

Outcome Description:

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.

Outcome Time Frame:

12 weeks

Safety Issue:

Yes

Principal Investigator

Luke J Peppone, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester

Authority:

United States: Institutional Review Board

Study ID:

25741

NCT ID:

NCT01293682

Start Date:

November 2010

Completion Date:

May 2013

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

University of RochesterRochester, New York  14642