Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors

Joint Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509079
• Other study ID #: 03962-10C
• Status: Completed
• Phase: Phase 2
• Start date: March 2012
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: March 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Joint Pain
• Muscle Pain
• Myalgia

Intervention

Drug:
• Vitamin D3
Cholecalciferol capsule, 4000IU, daily for 6 months
• Vitamin D3
cholecalciferol capsule, 600 IU, daily for 6 months

Locations

Country	Name	City	State
United States	Park Nicollet Frauenshuh Cancer Center	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HealthPartners Institute	University of Minnesota - Clinical and Translational Science Institute, University of Southern California

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.100 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Hand Grip Strength		baseline to 6 months
Secondary	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
Secondary	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
Secondary	Serum Estradiol Concentrations		baseline and 6 months
Secondary	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
Secondary	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
Secondary	Vitamin D Binding Protein Genotype		Baseline