NCT01051609

Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients

Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare pre and post Aromatase Inhibitor (AI) treatment serological markers of inflammation and assess for correlation with AI-MS.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	History and Physical Exam	The physical exam includes vital signs and ECOG performance status.
OTHER	Grip Strength Measurement	A hand grip strength test will be used to measure and compare baseline and post-AI treatment forearm muscle strength in each hand.
BEHAVIORAL	Surveys	Self-administered surveys including Health Assessment Questionnaire Disability Index, CES-D, FACIT-F, PSQI, GAD7, number of minutes of morning stiffness, and questions pertaining to vasomotor symptoms will be used in this study to assess for presence, severity, characteristics, and associations of AI-associated musculoskeletal symptoms.
OTHER	Blood Collection	A set of blood markers will be assayed at baseline, 6 months, and 12 months.
PROCEDURE	Ultrasound of Hand/Wrist	An inflammatory arthritis ultrasound scoring method similar to the RAMRIS scoring system used in rheumatoid arthritis, will evaluate joints in the most affected hand and wrist at 6 months.

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-07-01
• First posted: 2010-01-18
• Last updated: 2016-09-09

Locations

1 site across 1 country: United States