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.

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.

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

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).

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

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

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

Shapiro AC, Adlis SA, Robien K, Kirstein MN, Liang S, Richter SA, Lerner RE. Randomized, blinded trial of vitamin D3 for treating aromatase inhibitor-associated musculoskeletal symptoms (AIMSS). Breast Cancer Res Treat. 2016 Feb;155(3):501-12. doi: 10.1007/s10549-016-3710-6. Epub 2016 Feb 11. Erratum In: Breast Cancer Res Treat. 2016 Jun;157(2):403.