Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Park Nicollet Institute
Sponsor:
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: February 26, 2014
Last verified: February 2014
  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
Official Title: Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • Musculoskeletal symptom sub-scale on the Breast Cancer Prevention Trial 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: January 2015
Estimated Primary Completion Date: April 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
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: NCT01509079

Contacts
Contact: Shapiro C Alice, PhD RD LN 952-993-1704 shapia@parknicollet.com
Contact: Ann Deshler, RN 952-993-3582 ann.deshler@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: 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: February 26, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthralgia
Myalgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Muscular Diseases
Musculoskeletal Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
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 August 28, 2014