Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Orthopedic |
| Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | March 2012 |
| End Date: | March 2015 |
Phase 2 Study 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.
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.
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.
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
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