Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS), Breast Cancer
Conditions
Keywords
Aromatase Inhibitor Induced Musculoskeletal Syndrome, AIMSS, Breast Cancer, Biomarkers, Oxylipin
Brief summary
This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.
Detailed description
This is a prospective single arm study enrolling patients (n = 25) with breast cancer scheduled to start adjuvant hormonal therapy. Patients would have completed all their primary treatments (surgery± radiation therapy) and are scheduled to start their adjuvant hormonal therapy. They get baseline blood drawn for oxylipins and sheer wave elastrography (SWE) ultrasound of their hands including wrists. They start adjuvant anastrozole and have blood drawn at 3mths and 6mths for measurement of oxylipins. SWE ultrasound is repeated at 6mths. This is a pilot trial to evaluate for blood and imaging biomarkers. Once pilot data is analyzed, goal is to apply for funding for a larger trial to further evaluate and validate these biomarkers
Interventions
DIAGNOSTIC_TESTInitial blood draw
At baseline, patients will undergo a blood draw.
DIAGNOSTIC_TESTInitial SWE ultrasound
At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.
DIAGNOSTIC_TESTBlood draw at three months
Blood drawn at three months to evaluate oxylipins.
DIAGNOSTIC_TESTBlood draw at six months
Blood drawn at six months to evaluate oxylipins.
DIAGNOSTIC_TESTSWE ultrasound at six months
SWE ultrasound at six months to evaluate tendon stiffness.
Sponsors
University of Arizona
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be capable of understanding the investigational nature of the study and all pertinent aspects of the study 2. Be capable of signing and providing written consent in accordance with institutional and federal guidelines 3. Have a histologically-confirmed diagnosis of breast cancer 4. Be willing and able to comply with scheduled visits, treatment plan, and SWE ultrasound imaging 5. Age ≥ 21 years 6. Post-menopausal women with 1st event of ER+ early stage breast cancer (0-3) 7. Completed definitive therapy (surgery ± radiation) 8. Candidates for adjuvant AI therapy
Exclusion criteria
1. Have received adjuvant or neo-adjuvant chemotherapy 2. Prior endocrine therapy (AI or tamoxifen) 3. History of rheumatoid arthritis or other autoimmune arthritis 4. Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use) 5. Current use of daily corticosteroids or immunosuppressive therapies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxylipin Levels | Baseline, Three months, and Six months | Change Oxylipin levels at Baseline, Three and Six Months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tendon Stiffness | Baseline | Tendon stiffness at baseline |
| Pain Levels | Baseline, Six months | Pain levels at baseline and 6 months. Pain assessment was done using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index; the WOMAC pain assessment consists of 5 items, and each item has a scale that ranges from 0-4 (higher scores indicate higher pain levels). The scores of the 5 items are summed up to obtain the WOMAC-total pain score, which ranges from 0-20. |
Countries
United States
Participant flow
Recruitment details
Postmenopausal women with early-stage breast cancer prior to starting adjuvant endocrine therapy with aromatase inhibitors
Pre-assignment details
This is a single arm observational study
Participants by arm
| Arm | Count |
|---|---|
| Participants Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy.
Initial blood draw: At baseline, patients will undergo a blood draw.
Initial SWE ultrasound: At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.
Blood draw at three months: Blood drawn at three months to evaluate oxylipins.
Blood draw at six months: Blood drawn at six months to evaluate oxylipins.
SWE ultrasound at six months: SWE ultrasound at six months to evaluate tendon stiffness. | 28 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Age, Continuous | 66.0 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 0 Participants |
| Stage of Cancer Stage 0 | 8 Participants |
| Stage of Cancer Stage 1 | 17 Participants |
| Stage of Cancer Stage 2 | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Oxylipin Levels
Change Oxylipin levels at Baseline, Three and Six Months
Time frame: Baseline, Three months, and Six months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants | Oxylipin Levels | Baseline | 10.2 pg/mL | Standard Deviation 5.9 |
| Participants | Oxylipin Levels | 3 Months | 12.1 pg/mL | Standard Deviation 7.8 |
| Participants | Oxylipin Levels | 6 Months | 12.3 pg/mL | Standard Deviation 9.8 |
p-value: 0.684Mixed Models Analysis
Secondary
Pain Levels
Pain levels at baseline and 6 months. Pain assessment was done using the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index; the WOMAC pain assessment consists of 5 items, and each item has a scale that ranges from 0-4 (higher scores indicate higher pain levels). The scores of the 5 items are summed up to obtain the WOMAC-total pain score, which ranges from 0-20.
Time frame: Baseline, Six months
Population: Patients with early stage breast cancer on adjuvant aromatase inhibitor.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants | Pain Levels | Baseline | 8.0 score on a scale | Standard Deviation 14.6 |
| Participants | Pain Levels | 6 Months | 12.3 score on a scale | Standard Deviation 17.6 |
p-value: 0.058Mixed Models Analysis
Secondary
Tendon Stiffness
Tendon stiffness at baseline
Time frame: Baseline
Population: Patients with breast cancer on adjuvant aromatase inhibitor.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants | Tendon Stiffness | Abductor pollicis longus (Baseline) | 5.59 m/s | Standard Deviation 2.46 |
| Participants | Tendon Stiffness | Median nerve (Baseline) | 5.56 m/s | Standard Deviation 2.08 |
p-value: 0.02Mixed Models Analysis