Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Muscle Pain, Joint Pain

Intervention / Treatment
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* Drug: Vitamin D3
* Drug: Vitamin D3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D3 4000 IU<br> | Drug: Vitamin D3<br>* Cholecalciferol capsule, 4000IU, daily for 6 months<br>|
| Active Comparator: Vitamin D3 600 IU<br> | Drug: Vitamin D3<br>* cholecalciferol capsule, 600 IU, daily for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale | The MS subscale is a self-reported measure on a scale of 0 to 4, with lower score indicating less arthralgia/myalgia | baseline to 6 months | 
| Change in Hand Grip Strength |  | baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROMIS Physical Functioning Questionnaire | 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). | baseline to 6 months | 
| Average Percent Adherence to Vitamin D Interventio | adherence measured with pill counts for the vitamin D at predesignated study timepoints: baseline (after run-in), 3 months and 6 months | average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months | 
| Serum Estradiol Concentrations |  | baseline and 6 months | 
| Change in Steady State Concentrations of Serum Anastrazole and Letrozole | Difference in steady state concentrations in plasma from baseline to 6 months | baseline to 6 months | 
| Whole Body Bone Mineral Density | GLM Mean and standard deviation of Whole Body Bone Mineral Density (grams/cm2) of Trial Participants by Treatment Arm after controlling for bisphosphonate use | From Baseline and 6 months of D3 supplementation | 
| Vitamin D Binding Protein Genotype |  | Baseline |