Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
This study is currently recruiting participants.
Verified December 2011 by Park Nicollet Institute
Sponsor:
Park Nicollet Institute
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
University of Southern California
Information provided by (Responsible Party):
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01509079
First received: December 12, 2011
Last updated: October 30, 2012
Last verified: December 2011
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Purpose
The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.
| Condition | Intervention | Phase |
|---|---|---|
|
Muscle Pain Joint Pain |
Drug: Vitamin D3 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care |
Resource links provided by NLM:
Further study details as provided by Park Nicollet Institute:
Primary Outcome Measures:
- Musculoskeletal symptoms on the BCPT symptom scale [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
- Hand Grip Strength [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
- PROMIS Physical Functioning Questionnaire [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Medication adherence [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
- Serum Hormones [ Time Frame: Change from baseline to 6 months ] [ Designated as safety issue: No ]
- Serum AI concentrations [ Time Frame: AUC for 0, 2, 4 hours post-dose, change from baseline to 6 months ] [ Designated as safety issue: No ]
- Bone Mineral Density [ Time Frame: Change from screen to 6 months ] [ Designated as safety issue: No ]
- Vitamin D binding protein genotype [ Time Frame: Baseline ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Vitamin D3 4000 IU |
Drug: Vitamin D3
Cholecalciferol capsule, 4000IU, daily for 6 months
|
| Active Comparator: Vitamin D3 600 IU |
Drug: Vitamin D3
cholecalciferol capsule, 600 IU, daily for 6 months
|
Detailed Description:
This project will determine the efficacy of vitamin D3 supplements for reducing side effects of treatment with aromatase inhibitors in women with a history of breast cancer that have no evidence of current disease. The aromatase inhibitors (AI) have become a critical component of adjuvant therapy for this population, but they cause bone pain, joint pain, joint stiffness, and muscle weakness in approximately 40% of patients. These symptoms, referred to as aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), decrease quality of life and medication adherence. Identifying effective ways to decrease these symptoms may allow for longer and more adherent medication use and thus may improve disease-free survival. We hypothesize that vitamin D3 may decrease symptoms associated with the use of aromatase inhibitors.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Women with a history of stage I-IIIa invasive breast cancer
- History of hormone-receptor positive cancer (either ER + or PR + or both)
- Are prescribed and are taking anastrozole, letrozole or exemestane for at least one month and have at least 7 months of AI treatment remaining
- Are experiencing AIMSS
Exclusion Criteria:
- Unable to read or understand English
- History of psychiatric disability affecting informed consent or compliance with drug intake
- Malabsorption syndrome or inability to take oral medication
- Has less than 7 months of AI therapy remaining
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509079
Contacts
| Contact: Shapiro C Alice, PhD RD LN | 952-993-1704 | shapia@parknicollet.com |
| Contact: Karen Swenson, PhD RN | 952-993-6071 | swensk@parknicollet.com |
Locations
| United States, Minnesota | |
| Park Nicollet Frauenshuh Cancer Center | Recruiting |
| Minneapolis, Minnesota, United States, 55416 | |
| Principal Investigator: Alice C Shapiro, PhD, RD, LN | |
| Sub-Investigator: Karen Swenson, PhD RN | |
| Sub-Investigator: Rachel Lerner, MD, MS | |
Sponsors and Collaborators
Park Nicollet Institute
University of Minnesota - Clinical and Translational Science Institute
University of Southern California
Investigators
| Principal Investigator: | Alice C. Shapiro, PhD RD | Park Nicollet Health Services |
More Information
No publications provided
| Responsible Party: | Park Nicollet Institute |
| ClinicalTrials.gov Identifier: | NCT01509079 History of Changes |
| Other Study ID Numbers: | 03962-10C |
| Study First Received: | December 12, 2011 |
| Last Updated: | October 30, 2012 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthralgia Joint Diseases Musculoskeletal Diseases Pain Signs and Symptoms Cholecalciferol Vitamin D Ergocalciferols Vitamins |
Aromatase Inhibitors Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013