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

NCT01051609 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 27

Last updated 2016-09-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Sara Hurvitz, M D · University of California, Los Angeles

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2013-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01051609 on ClinicalTrials.gov