- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01419730
Vitamin D and Physical Activity on Bone Health
The Effect of High-Dose Vitamin D and Physical Activity on Bone Health in Breast Cancer Patients Receiving Hormonal Therapy
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Must be female and have a primary diagnosis of Stage I, II, or III hormone-receptor positive breast cancer.
- Women must be postmenopausal at time of enrollment.
- 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 < 10.6 mg/dl.
- Participants must be slightly vitamin D deficient (serum vitamin D level <32ng/ml)
- Must have a functional capacity rating of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) performance status when assessed at baseline.132
- 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 24-week supplementation of vitamin D.
- Must be less than five years from the diagnosis of breast cancer and must be within 12 months of starting treatment with aromatase inhibitors (AI) in accordance with American Society of Clinical Oncology (ASCO) guidelines.
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 ≥ 10.6 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 vitamin D.
- Patients who are severely vitamin D deficient (<10 ng/ml).
- 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 with malabsorptive syndromes (i.e. cystic fibrosis, chronic pancreatitis) or taking medications that decrease the absorption of fat soluble vitamins (i.e. Orlistat, Questran).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Vitamin D3 50,000 IU
Vitamin D3 50,000 IU: Patients will be assigned to receive a daily multivitamin, calcium supplement and 50,000 IU/week of vitamin D for a period of 24 weeks.
|
Vitamin D3 50,000 IU
|
Active Comparator: Vitamin D3 50,000 IU and Physical Activity
Vitamin D3 50,000 IU and Physical Activity: Patients will be assigned to receive a daily multivitamin, calcium supplement, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks.
|
Vitamin D3 50,000 IU
Progressive walking and resistance band exercise prescription for a period of 24 weeks
|
No Intervention: Control
Patients will be assigned to receive a daily multivitamin, calcium supplement, vitamin D placebo, and standard care monitoring.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure the amount of bone loss in non-metastatic breast cancer patients receiving a high dose vitamin D therapy along with a structured home-based walking and progressive resistance exercise program.
Time Frame: 24 weeks
|
To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone metabolism biomarkers in non-metastatic breast cancer patients who began hormonal therapy within the previous 12 months. To collect preliminary data on the effects of vitamin D therapy and exercise (alone or in combination) on bone mineral density (BMD) as measured by a dual energy X-ray absorptiometry (DXA) in non-metastatic breast cancer patients who began hormonal therapy within the previous 12 months. |
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure the effect of vitamin D and exercise on physical fitness in non-metastatic breast cancer patients
Time Frame: 24 weeks
|
Measuring physical fitness includes balance, aerobic capacity, and muscle strength in non-metastatic breast cancer patients who begin hormonal therapy within the previous 12 months.
|
24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Luke J Peppone, PhD, MPH, University of Rochester
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 34834
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bone Mineral Density
-
State University of New York - Upstate Medical...Completed
-
Duramed ResearchCompletedBone Mineral DensityUnited States
-
St. Jude Children's Research HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedBone Mineral Density | Bone StrengthUnited States
-
St. Vincent Hospital, ViennaCompletedBone Mineral Density
-
University of California, San FranciscoMayo ClinicCompletedBone Mineral DensityUnited States
-
University of AarhusCompletedBone Mineral Density | Osseointegrated Implants
-
Children's Hospital Medical Center, CincinnatiEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Tel-Aviv Sourasky Medical CenterUnknownBone Mineral Density | Vegan DietIsrael
-
Insud PharmaChemo ResearchActive, not recruitingContraception | Change in Bone Mineral DensityUnited States
-
Universidade Norte do ParanáCompletedBone Mineral Density Quantitative Trait Locus 3Brazil
Clinical Trials on Vitamin D3
-
Aga Khan UniversityCompletedVitamin D DeficiencyPakistan
-
Medical University of South CarolinaThrasher Research FundCompletedVitamin D Deficiency | PregnancyUnited States
-
Brigham and Women's HospitalNational Center for Maternal and Child Health Research, Mongolia; Zuun Kharaa...CompletedVitamin D Deficiency | PregnancyMongolia
-
Rutgers UniversityCompleted
-
Aalborg UniversityAalborg University Hospital; CCBR Aalborg A/S, Aalborg, DenmarkCompletedMigraine According to International Headache Society (IHS) Criteria (ICHD-II)Denmark
-
University of North Carolina, Chapel HillNational Institute on Drug Abuse (NIDA); Eunice Kennedy Shriver National Institute... and other collaboratorsCompletedHIV InfectionUnited States, Puerto Rico
-
Nationwide Children's HospitalOhio State UniversityUnknownVitamin D Deficiency | AsthmaUnited States
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Sanjay Gandhi Postgraduate Institute of Medical...CompletedPancreatitis, ChronicIndia
-
Mahidol UniversityUnknownCritical Illness | Vitamin D Deficiency | SarcopeniaThailand