Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS)NCT03665077
Evaluation of Blood/Imaging Based Biomarkers, Aromatase Inhibitor Induced Musculoskeletal Syndrome
A study testing Initial blood draw, Initial SWE ultrasound and Blood draw at three months in people with Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS) and Breast Cancer, run by University of Arizona at 1 site in United States.
Trial summary
This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS), Breast Cancer
- What is being tested?
- Initial blood draw, Initial SWE ultrasound and Blood draw at three months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 15 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
- Be capable of signing and providing written consent in accordance with institutional and federal guidelines
- Have a histologically-confirmed diagnosis of breast cancer
- Be willing and able to comply with scheduled visits, treatment plan, and SWE ultrasound imaging
- Age ≥ 21 years
- Post-menopausal women with 1st event of ER+ early stage breast cancer (0-3)
- Completed definitive therapy (surgery ± radiation)
- Candidates for adjuvant AI therapy
Who cannot join
- Have received adjuvant or neo-adjuvant chemotherapy
- Prior endocrine therapy (AI or tamoxifen)
- History of rheumatoid arthritis or other autoimmune arthritis
- Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use)
- Current use of daily corticosteroids or immunosuppressive therapies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arizona Cancer Center
Tucson, Arizona, 85724
About this study
Official title: Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome
This is a pilot trial to evaluate for blood and imaging biomarkers in patients with breast cancer scheduled to start adjuvant hormonal therapy.
Read the 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
- Being tested
- Initial blood draw, Initial SWE ultrasound, Blood draw at three months, Blood draw at six months, SWE ultrasound at six months
- Keywords
- Aromatase Inhibitor Induced Musculoskeletal Syndrome, AIMSS, Breast Cancer, Biomarkers, Oxylipin
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial blood drawDiagnostic test
At baseline, patients will undergo a blood draw.
Initial SWE ultrasoundDiagnostic test
At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.
Blood draw at three monthsDiagnostic test
Blood drawn at three months to evaluate oxylipins.
Blood draw at six monthsDiagnostic test
Blood drawn at six months to evaluate oxylipins.
SWE ultrasound at six monthsDiagnostic test
SWE ultrasound at six months to evaluate tendon stiffness.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Patients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy. Receives: Diagnostic Test: Initial blood draw; Diagnostic Test: Initial SWE ultrasound; Diagnostic Test: Blood draw at three months; Diagnostic Test: Blood draw at six months; Diagnostic Test: SWE ultrasound at six months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxylipin Levels
Change Oxylipin levels at Baseline, Three and Six Months
Measured: Baseline, Three months, and Six months
Secondary outcomes (2)
Tendon Stiffness
Tendon stiffness at baseline
Measured: Baseline
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.
Measured: Baseline, Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start28 Feb 2018
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS)Studies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavani Chalasani, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665077
- Sponsor's protocol ID
- 1712078374
- Other IDs
- NCI-2018-00099
- Status last verified
- Aug 2023
- First submitted
- 7 Sep 2018
- Last updated
- 24 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial to Evaluate Blood and Imaging Based Biomarkers for Aromatase Inhibitor Induced Musculoskeletal Syndrome
- ClinicalTrials.gov ID
- NCT03665077
- Acronym / sponsor ID
- 1712078374
- Keywords
- Aromatase Inhibitor Induced Musculoskeletal Syndrome, AIMSS, Breast Cancer, Biomarkers, Oxylipin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 11 Sep 2018 (actual)
- Results
- Posted 14 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Diagnostic Test: Initial blood draw, Diagnostic Test: Initial SWE ultrasound, Diagnostic Test: Blood draw at three months, Diagnostic Test: Blood draw at six months, Diagnostic Test: SWE ultrasound at six monthsPatients with breast cancer who have completed all their primary treatments (surgery±radiation therapy) and are scheduled to start their adjuvant hormonal therapy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
- Be capable of signing and providing written consent in accordance with institutional and federal guidelines
- Have a histologically-confirmed diagnosis of breast cancer
- Be willing and able to comply with scheduled visits, treatment plan, and SWE ultrasound imaging
- Age ≥ 21 years
Key exclusion criteria (5 listed)
- Have received adjuvant or neo-adjuvant chemotherapy
- Prior endocrine therapy (AI or tamoxifen)
- History of rheumatoid arthritis or other autoimmune arthritis
- Daily non-steroidal anti-inflammatory drug (NSAID) use (except for daily aspirin use)
- Current use of daily corticosteroids or immunosuppressive therapies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial blood drawAt baseline, patients will undergo a blood draw. | Diagnostic test | Participants |
| Initial SWE ultrasoundAt baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists. | Diagnostic test | Participants |
| Blood draw at three monthsBlood drawn at three months to evaluate oxylipins. | Diagnostic test | Participants |
| Blood draw at six monthsBlood drawn at six months to evaluate oxylipins. | Diagnostic test | Participants |
| SWE ultrasound at six monthsSWE ultrasound at six months to evaluate tendon stiffness. | Diagnostic test | Participants |
Primary outcome
Oxylipin Levels
Time frame: Baseline, Three months, and Six months
Change Oxylipin levels at Baseline, Three and Six Months
2 secondary outcomes
Tendon Stiffness
Time frame: Baseline
Pain Levels
Time frame: Baseline, Six months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Oxylipins as Biomarkers for Aromatase Inhibitor-Induced Arthralgia (AIA) in Breast Cancer PatientsLink provided by the sponsor.
- Feasibility Trial to Evaluate Tendon Stiffness Obtained from Shear Wave Elastography Imaging as a Biomarker of Aromatase Inhibitor-Induced ArthralgiasLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavani Chalasani principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial blood draw, Initial SWE ultrasound and Blood draw at three months in people with Aromatase Inhibitor Induced Musculoskeletal Syndrome (AIMSS) and Breast Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxylipin Levels (time frame: Baseline, Three months, and Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.