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

Completed

• Conditions: Breast Cancer
• Interventions: Other: History and Physical Exam; Other: Grip Strength Measurement; Behavioral: Surveys; Other: Blood Collection; Procedure: Ultrasound of Hand/Wrist

• Registration Number: NCT01051609
• Lead Sponsor: Jonsson Comprehensive Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Study Start: 2010-05
• Primary Completion: 2013-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

• Women 18 years and older with non-metastatic hormone receptor (ER and/or PR) positive breast cancer who are eligible for and planning on starting treatment with an AI within one month of signing consent.
• Postmenopausal, defined as at least one of the following: a) amenorrhea for at least 12 months b) prior bilateral oophorectomy at least 2 years prior to trial registration.

Exclusion Criteria

• History of autoimmune connective tissue disease, such as rheumatoid arthritis, lupus, or other autoimmune conditions affecting joints.
• Treatment with steroid (for any condition, except for chemotherapy premedication) within 30 days of trial registration.
• Prior treatment with an AI (patients previously or currently on tamoxifen are eligible as long as patients are off tamoxifen for 2 weeks prior to baseline blood draw)
• Active or ongoing infection
• Known metastatic disease
• Known history of HIV or hepatitis infections
• Ongoing radiation therapy (radiation must have been completed 2 weeks prior to starting treatment with an AI)
• Non-invasive (DCIS, LCIS) cancer only (no diagnosis of invasive cancer)
• Pregnant or lactating
• Unable to speak, read, and write in English

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervention Group	Surveys	There is only one arm in this trial. Please see interventions for more detailed descriptions.
Intervention Group	Blood Collection	There is only one arm in this trial. Please see interventions for more detailed descriptions.
Intervention Group	Ultrasound of Hand/Wrist	There is only one arm in this trial. Please see interventions for more detailed descriptions.
Intervention Group	History and Physical Exam	There is only one arm in this trial. Please see interventions for more detailed descriptions.
Intervention Group	Grip Strength Measurement	There is only one arm in this trial. Please see interventions for more detailed descriptions.

Primary Outcome Measures

Name	Time	Method
Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score.	Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor

Trial Locations

Locations (1)

UCLA Jonsson Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States