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Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients
This study is currently Recruiting
June 2011 By University of California, Los Angeles
First Recieved on January 15, 2010
Last Updated on June 17, 2011
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.
||Intervention Model: Single Group Assignment, Masking: Open Label
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
There is only one arm in this trial. Please see interventions for more detailed descriptions.
|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.
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.
|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.
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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
- 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
- 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
- Investigator: Sara Hurvitz, M D - Principal Investigator - University of California, Los Angeles