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
This is a pilot study designed to examine changes in muscle function after Aromatase Inhibitor (AI) therapy, at both the molecular and clinical level.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Changes in calstabin1 binding to RyR1 channels in skeletal muscle | Changes in calstabin1 binding to RyR1 channels in skeletal muscle of breast cancer patients pre and post exposure to adjuvant aromatase inhibitor therapy | through day 168 of aromatase inhibitor therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in ryanodine receptor/calcium release channel (RyR1) oxidation in skeletal muscle | To estimate changes in RyR1 oxidation in skeletal muscle of breast cancer patients, pre- and post- exposure to adjuvant aromatase inhibitor therapy | through day 168 of aromatase inhibitor therapy |
| Relationship between changes in RyR1 biochemistry and measures of muscle function |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Post menopausal women with non metastatic breast cancer planning to initiate aromatase inhibitor therapy at the IU Simon Cancer Center oncology clinic.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tarah Ballinger, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IU Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Serum blood samples will be collected to measure markers of bone turnover and to perform a serum TGF-β assay. Samples will be collected at baseline and within 14 days of day 168 of aromatase inhibitor (AI) treatment
Skeletal muscle tissue will be collected and used to compare relative calstabin1 to RyR1 and RyR1 oxidation before and after exposure to aromatase inhibitor (AI) treatment. One sample will be stored for future research relating to aromatase inhibitor-induced muscle weakness including proteomic research. Four core needle samples will be taken from the quadriceps muscle at baseline and within 14 days of day 168 of AI treatment.
To explore the relationship between changes in RyR1 biochemistry and measures of muscle function, including muscle power as measured by isokinetic dynamometry |
| through day 168 of aromatase inhibitor therapy |
| Relationship between markers of bone turnover and changes in RyR1 biochemistry | To explore the relationship between markers of bone turnover and changes in RyR1 biochemistry (calstabin binding to RyR1) | through day 168 of aromatase inhibitor therapy |
| Relationship between markers of bone turnover and changes in muscle function | To explore the relationship between markers of bone turnover and changes in muscle function in terms of muscle power assessed by isokinetic dynamometry | through day 168 of aromatase inhibitor therapy |
| Characterize the timing of development of muscle dysfunction following initiation of aromatase inhibitor therapy | To better characterize the timing of development of muscle dysfunction following initiation of aromatase inhibitor therapy, in terms muscle power measured by isokinetic dynamometry | through day 168 of aromatase inhibitor therapy |
| Feasibility of repeated muscle biopsies in patients with early stage breast cancer initiating aromatase inhibitor therapy | 5. To describe the feasibility of repeated muscle biopsies in patients with early stage breast cancer initiating aromatase inhibitor therapy, in terms of rate of completion of baseline and follow up biopsy | through day 168 of aromatase inhibitor therapy |
| D017437 |
| Skin and Connective Tissue Diseases |