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Completed

NCT Number: NCT01509079

Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

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.

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Key information

Conditions

Muscle Pain Arthralgia Joint Diseases Joint Pain Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Park Nicollet Frauenshuh Cancer Center

Minneapolis, Minnesota, 55416, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Drug

Cholecalciferol capsule, 4000IU, daily for 6 months

Primary outcomes

  1. Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale

    Time frame: baseline to 6 months

    The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia

  2. Change in Hand Grip Strength

    Time frame: baseline to 6 months

Secondary outcomes

  1. Change in PROMIS Physical Functioning Questionnaire

    Time frame: baseline to 6 months

    PROMIS measures physical functioning on the short form and higher scores reflect better physical functioning with 10 questions on daily activities of life on a Likert scale ranging from 5 (no problem performing activity) to 1 (cannot do activity). Range on this measure is from 50 (best)-10 (worst).

  2. Average Percent Adherence to Vitamin D Interventio

    Time frame: average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months

    adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months

  3. Serum Estradiol Concentrations

    Time frame: baseline and 6 months

  4. Change in Steady State Concentrations of Serum Anastrazole and Letrozole

    Time frame: baseline to 6 months

    Difference in steady state concentrations in plasma from baseline to 6 months

  5. Whole Body Bone Mineral Density

    Time frame: From Baseline and 6 months of D3 supplementation

    GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use

  6. Vitamin D Binding Protein Genotype

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • University of Minnesota
  • University of Southern California

Registry information

Official study title

Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Jan 12, 2012
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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