Clinical trial NCT01509079: Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
Official title: Phase 2 Study Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Pain
Joint Pain
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: University of Southern California
First posted: 2012-01-12
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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 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

Primary outcomes:
measure: Change in Musculoskeletal Symptom Sub-scale on the Breast Cancer Prevention Trial Symptom Scale
timeFrame: baseline to 6 months
measure: Change in Hand Grip Strength
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Change in PROMIS Physical Functioning Questionnaire
timeFrame: baseline to 6 months
measure: Average Percent Adherence to Vitamin D Interventio
timeFrame: average for all study ppts for: screening to baseline; baseline to 3 months; 3 month to 6 months
measure: Serum Estradiol Concentrations
timeFrame: baseline and 6 months
measure: Change in Steady State Concentrations of Serum Anastrazole and Letrozole
timeFrame: baseline to 6 months
measure: Whole Body Bone Mineral Density
timeFrame: From Baseline and 6 months of D3 supplementation
measure: Vitamin D Binding Protein Genotype
timeFrame: Baseline
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Park Nicollet Frauenshuh Cancer Center
state: Minnesota
Study officials:
affiliation: Park Nicollet Health Services
name: Alice C. Shapiro, PhD RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.