An observational study in Breast Cancer, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-09.
Sponsored by Jonsson Comprehensive Cancer Center · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 27 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
There is only one arm in this trial. Please see interventions for more detailed descriptions.
Other: History and Physical Exam · Other: Grip Strength Measurement · Behavioral: Surveys · Other: Blood Collection · Procedure: Ultrasound of Hand/Wrist
The physical exam includes vital signs and ECOG performance status.
A hand grip strength test will be used to measure and compare baseline and post-AI treatment forearm muscle strength in each hand.
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.
A set of blood markers will be assayed at baseline, 6 months, and 12 months.
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.
Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score.
Time frame: Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Jonsson Comprehensive Cancer Center