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Calcitriol, Physical Activity, and Bone Health in Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Luke Peppone, University of Rochester
ClinicalTrials.gov Identifier:
NCT00904033
First received: May 15, 2009
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Bone and Bones
Drug: calcitriol
Behavioral: Exercise
Dietary Supplement: Multivitamin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of the Effects of High-Dose Oral Calcitriol and Physical Activity on Bone Health in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Bone resorption [ Time Frame: Day 0, Week 12 ] [ Designated as safety issue: No ]
  • Bone formation [ Time Frame: Day 0, Week 12 ] [ Designated as safety issue: No ]
  • Serum calcium [ Time Frame: Day 0, Day 5, Week 6, Week 12 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Strength [ Time Frame: Day 0, Week 12 ] [ Designated as safety issue: No ]
  • Muscle mass [ Time Frame: Day 0, Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: December 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1Calcitriol
Calcitriol
Drug: calcitriol
Will receive pill once a week
Experimental: 2 Exericse
Home based walking and resistance band training
Behavioral: Exercise
Progressive walking and resistance band training
Experimental: 3 Calcitriol and Exericse Drug: calcitriol
Will receive pill once a week
Behavioral: Exercise
Progressive walking and resistance band training
Active Comparator: 4 Multivitamin Dietary Supplement: Multivitamin
One daily multivitamin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904033

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Luke J Peppone, Ph.D. University of Rochester
  More Information

No publications provided

Responsible Party: Luke Peppone, Research Assistant Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00904033     History of Changes
Other Study ID Numbers: RSRB00025478
Study First Received: May 15, 2009
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Calcitriol
Bone Density Conservation Agents
Calcium Channel Agonists
Cardiovascular Agents
Growth Substances
Membrane Transport Modulators
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasoconstrictor Agents
Vitamins

ClinicalTrials.gov processed this record on November 27, 2014