Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

HealthPartners Institute116 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

116

Conditions

Muscle Pain Joint Pain

Interventions

Vitamin D3DRUG

Cholecalciferol capsule, 4000IU, daily for 6 months

Vitamin D3DRUG

cholecalciferol capsule, 600 IU, daily for 6 months

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Park Nicollet Frauenshuh Cancer Center

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

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

Time frame: baseline to 6 months

Change in Hand Grip Strength

Time frame: baseline to 6 months

Secondary Outcomes

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).

Time frame: 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

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

Serum Estradiol Concentrations

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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