Calcitriol, Physical Activity, and Bone Health in Cancer Survivors

NCT ID: NCT00904033

Last Updated: 2019-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-01
• Study Completion Date: 2018-01-01

Brief Summary

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.

Detailed Description

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.

Conditions

Breast Neoplasms; Bone and Bones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Multivitamin

Multivitamin used as control group.

Group Type: ACTIVE_COMPARATOR

Multivitamin

Intervention Type: DIETARY_SUPPLEMENT

Exercise

Exercise consisting of progressive walking and resistance band training.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

Exercise consisting of progressive walking and resistance band training

Calcitriol

Calcitriol pill taken once per week.

Group Type: EXPERIMENTAL

Calcitriol

Intervention Type: DRUG

Calcitriol tablet taken once per week.

Calcitriol and Exercise

Calcitriol pill taken once per week plus Exercise consisting of progressive walking and resistance band training.

Group Type: EXPERIMENTAL

Calcitriol

Intervention Type: DRUG

Calcitriol tablet taken once per week.

Exercise

Intervention Type: BEHAVIORAL

Exercise consisting of progressive walking and resistance band training

Interventions

Calcitriol

Calcitriol tablet taken once per week.

Intervention Type: DRUG

Exercise

Exercise consisting of progressive walking and resistance band training

Intervention Type: BEHAVIORAL

Multivitamin

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Control

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Luke Peppone

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luke J Peppone, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RSRB00025478

Identifier Type: -

Identifier Source: org_study_id