Both the calcitriol and exercise interventions are aimed at reducing fracture risk by
maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and
increasing muscle mass. Both calcitriol and exercise are efficacious in maintaining proper
bone health and muscle mass among the general population, but little research has been done
on breast cancer patients and survivors. The combination of calcitriol and exercise, which
function through different but similar mechanisms, could produce interactive effects in
reducing fracture risk among breast cancer survivors.
Hypothesis: A combination of calcitriol along with a structured home-based walking and
progressive resistance exercise program will be efficacious in preventing bone resorption
and in increasing bone formation among survivors of invasive breast cancer.
Primary Objective
To collect data on the efficacy and feasibility of a supplementation of calcitriol
with/without an accompanying structured home-based walking/progressive resistance exercise
program for improving bone health among breast cancer survivors.
Secondary Objectives
To collect data on the efficacy and feasibility of a supplementation of calcitriol
with/without an accompanying structured home-based walking/progressive resistance exercise
program for increasing strength among breast cancer survivors.
To collect data on the efficacy and feasibility of a supplementation of calcitriol
with/without an accompanying structured home-based walking/progressive resistance exercise
program for improving skeletal muscle mass among breast cancer survivors.
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Inclusion Criteria:
- Must be female.
- 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.
- 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.
- Must have a functional capacity rating of ≤ 2 on the Eastern Cooperative Oncology
Group (ECOG) performance status when assessed at baseline.
- Must have the approval of their treating physician (or physician's nurse practitioner
or physician's assistant) to participate in sub-maximal physiological fitness testing
and a low to moderate home-based walking and progressive resistance exercise program
and to receive the 12-week supplementation of calcitriol 45 μg. Participants
assigned to either of the calcitriol treatment arms will be instructed to stop taking
calcium and/or vitamin D supplements.
- Must be less than five years from the diagnosis of breast cancer and have received
chemotherapy, radiation therapy, and/or hormonal therapy. Chemotherapy and radiation
therapy, if received, must have been completed prior to study enrollment. Hormonal
therapy may be ongoing.
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 who had a myocardial infarction within the past year.
- Patients with severe metabolic disorders, which includes phenylketonuria (PKU),
homocystinuria, and Fabry's disease, that would preclude them from taking calcitriol.
- 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 be
willing to 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.
- Previously verified diagnosed of osteoporosis.
- Women on antiresorptive drugs (e. g. bisphosphonates) within the past year.
- Patients not capable of participating in an exercise intervention due to severe knee
arthrosis or ligament/cartilage injuries of the lower extremities.
- 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.