Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | There is only one arm in this trial. Please see interventions for more detailed descriptions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| History and Physical Exam | Other | The physical exam includes vital signs and ECOG performance status. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sara Hurvitz, M D | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Jonsson Comprehensive Cancer Center | Los Angeles | California | 90095 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Grip Strength Measurement | Other | A hand grip strength test will be used to measure and compare baseline and post-AI treatment forearm muscle strength in each hand. |
|
| Surveys | Behavioral | 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. |
|
| Blood Collection | Other | A set of blood markers will be assayed at baseline, 6 months, and 12 months. |
|
| Ultrasound of Hand/Wrist | Procedure | 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. |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D055991 | Health Records, Personal |
| D012149 | Restraint, Physical |
| D011795 | Surveys and Questionnaires |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided