Breast CancerNCT01051609
Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients
An observational study of Breast Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- History and Physical Exam, Grip Strength Measurement and Surveys
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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 registration.
Who cannot join
- 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 draw)
- Active or ongoing infection
- Known metastatic disease
- Known history of HIV or hepatitis infections
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients
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.
- Conditions
- Breast Cancer
- Being tested
- History and Physical Exam, Grip Strength Measurement, Surveys, Blood Collection, Ultrasound of Hand/Wrist
- Keywords
- Post Menopausal, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
History and Physical ExamOther
The physical exam includes vital signs and ECOG performance status.
Grip Strength MeasurementOther
A hand grip strength test will be used to measure and compare baseline and post-AI treatment forearm muscle strength in each hand.
SurveysBehavioural
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 CollectionOther
A set of blood markers will be assayed at baseline, 6 months, and 12 months.
Ultrasound of Hand/WristProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | There is only one arm in this trial. Please see interventions for more detailed descriptions. Receives: Other: History and Physical Exam; Other: Grip Strength Measurement; Behavioral: Surveys; Other: Blood Collection; Procedure: Ultrasound of Hand/Wrist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score.
Measured: Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Hurvitz, M D, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01051609
- Sponsor's protocol ID
- 09-09-058
- Status last verified
- Sep 2016
- First submitted
- 15 Jan 2010
- Last updated
- 9 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Aromatase Inhibitor-Associated Musculoskeletal Symptoms in Non-Metastatic, Post Menopausal Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01051609
- Acronym / sponsor ID
- 09-09-058
- Conditions
- Breast Cancer
- Keywords
- Post Menopausal, Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2013 (actual)
- First posted
- 18 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | – | Other: History and Physical Exam, Other: Grip Strength Measurement, Behavioral: Surveys, Other: Blood Collection, Procedure: Ultrasound of Hand/WristThere is only one arm in this trial. Please see interventions for more detailed descriptions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (2 listed)
- 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 registration.
Key exclusion criteria (10 listed)
- 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 draw)
- Active or ongoing infection
- Known metastatic disease
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 |
|---|---|---|
| History and Physical ExamThe physical exam includes vital signs and ECOG performance status. | Other | Intervention Group |
| Grip Strength MeasurementA hand grip strength test will be used to measure and compare baseline and post-AI treatment forearm muscle strength in each hand. | Other | Intervention Group |
| SurveysSelf-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. | Behavioural | Intervention Group |
| Blood CollectionA set of blood markers will be assayed at baseline, 6 months, and 12 months. | Other | Intervention Group |
| Ultrasound of Hand/WristAn 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. | Procedure or surgery | Intervention Group |
Primary outcome
Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score.
Time frame: Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2016.
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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.
Sara Hurvitz, M D principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Jonsson Comprehensive Cancer Center 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 2 inclusion and 10 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 9 Sep 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence, severity, and change in severity of pain based on joint exam and joint ultrasound inflammatory score. (time frame: Study visits at 3, 6, 9 and 12 months after the start of treatment with an Aromatase Inhibitor). 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 9 Sep 2016; AzTrials last refreshed its copy on 8 Nov 2026.