Breast CancerAIMSNCT01074320
Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors
An observational study of Breast Cancer, run by HealthPartners Institute at 2 sites in United States.
Trial summary
Current guidelines recommend endocrine treatment with aromatase inhibitors (AIs) in post-menopausal women with hormone receptor-positive breast cancer. Musculoskeletal symptoms are commonly reported with AI treatment,however, we do not have consistent methods to measure these symptoms prospectively. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Other
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2010to Aug 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Post-menopausal breast cancer patients receiving aromatase inhibitors
Who may be able to join
- Women with stage I - IIIa invasive breast cancer,
- Hormone-receptor positive cancer (either ER+ or PR+ or both),
- Prescribed and have agreed to take exemestane, anastrazole or letrozole,
- Have completed initial treatment of surgery, RT, and/or chemotherapy,
- Are post-menopausal,
- No previous history of aromatase inhibitor therapy for invasive breast cancer,
- Have signed the consent form.
Who cannot join
- History of rheumatoid arthritis,
- Unable to read or understand English,
- History of psychiatric disability affecting informed consent or compliance with study procedures.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Memorial Medical Center
Robbinsdale, Minnesota, 55422
Park Nicollet Institute
Saint Louis Park, Minnesota, 55426
About this study
Current guidelines recommend endocrine treatment with aromatase inhibitors (AIs) in post-menopausal women with hormone receptor-positive breast cancer. Musculoskeletal symptoms are commonly reported with AI treatment,however, we do not have consistent methods to measure these symptoms prospectively. This gap in our knowledge inhibits the ability to test and develop treatments for AI-associated musculoskeletal symptoms. This pilot study will evaluate functional tests and standardized instruments for their ability to prospectively assess musculoskeletal symptoms in women being treated with AIs for breast cancer.
Read the detailed description
Specific Aims: 1) identify a core set of instruments for measuring musculoskeletal symptoms, 2) model the time course and predictors of change in musculoskeletal symptoms, 3) explore the effect of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment.
Methods: We will prospectively assess musculoskeletal symptoms due to treatment with aromatase inhibitors. Post-menopausal women beginning AI treatment for hormone responsive breast cancer will be invited to join this study.
- Conditions
- Breast Cancer
- Being tested
- Other
- Keywords
- breast cancer, aromatase inhibitors, musculoskeletal symptoms
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtherOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patients on AIs | Breast cancer patients beginning Aromatase Inhibitor therapy Receives: Other: Other |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify a core set of instruments for measuring musculoskeletal symptoms
Measured: 09/2011
Secondary outcomes (2)
Model the time course and predictors of change in musculoskeletal symptoms
Measured: 09/2011
Explore the effects of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment
Measured: 09/2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen K Swenson, RN, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01074320
- Sponsor's protocol ID
- 03918-09
- Acronym
- AIMS
- Status last verified
- Aug 2015
- First submitted
- 22 Feb 2010
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Swenson KK, Nissen MJ, Henly SJ, Maybon L, Pupkes J, Zwicky K, Tsai ML, Shapiro AC. Identification of tools to measure changes in musculoskeletal symptoms and physical functioning in women with breast cancer receiving aromatase inhibitors. Oncol Nurs Forum. 2013 Nov;40(6):549-57. doi: 10.1188/13.ONF.549-557.
PubMed 24161633
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors
- ClinicalTrials.gov ID
- NCT01074320
- Acronym / sponsor ID
- AIMS / 03918-09
- Conditions
- Breast Cancer
- Keywords
- breast cancer, aromatase inhibitors, musculoskeletal symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Feb 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.
Current guidelines recommend endocrine treatment with aromatase inhibitors (AIs) in post-menopausal women with hormone receptor-positive breast cancer. Musculoskeletal symptoms are commonly reported with AI treatment,however, we do not have consistent methods to measure these symptoms prospectively. This gap in our knowledge inhibits the ability to test and develop treatments for AI-associated musculoskeletal symptoms. This pilot study will evaluate functional tests and standardized instruments for their ability to prospectively assess musculoskeletal symptoms in women being treated with AIs for breast cancer.
Detailed description
Specific Aims: 1) identify a core set of instruments for measuring musculoskeletal symptoms, 2) model the time course and predictors of change in musculoskeletal symptoms, 3) explore the effect of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment.
Methods: We will prospectively assess musculoskeletal symptoms due to treatment with aromatase inhibitors. Post-menopausal women beginning AI treatment for hormone responsive breast cancer will be invited to join this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients on AIs | – | Other: OtherBreast cancer patients beginning Aromatase Inhibitor therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Post-menopausal breast cancer patients receiving aromatase inhibitors
Key inclusion criteria (7 listed)
- Women with stage I - IIIa invasive breast cancer,
- Hormone-receptor positive cancer (either ER+ or PR+ or both),
- Prescribed and have agreed to take exemestane, anastrazole or letrozole,
- Have completed initial treatment of surgery, RT, and/or chemotherapy,
- Are post-menopausal,
Key exclusion criteria (3 listed)
- History of rheumatoid arthritis,
- Unable to read or understand English,
- History of psychiatric disability affecting informed consent or compliance with study procedures.
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 |
|---|---|---|
| OtherObservational study | Other | Breast cancer patients on AIs |
Primary outcome
Identify a core set of instruments for measuring musculoskeletal symptoms
Time frame: 09/2011
2 secondary outcomes
Model the time course and predictors of change in musculoskeletal symptoms
Time frame: 09/2011
Explore the effects of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment
Time frame: 09/2011
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 16 Dec 2015.
- Results publication: PubMed 24161633Swenson KK, Nissen MJ, Henly SJ, Maybon L, Pupkes J, Zwicky K, Tsai ML, Shapiro AC. Identification of tools to measure changes in musculoskeletal symptoms and physical functioning in women with breast cancer receiving aromatase inhibitors. Oncol Nurs Forum. 2013 Nov;40(6):549-57. doi: 10.1188/13.ONF.549-557.
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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.
Karen K Swenson, RN, PhD principal investigator
HealthPartners Institute
2 sites 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 HealthPartners Institute at 2 sites 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 7 inclusion and 3 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 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Identify a core set of instruments for measuring musculoskeletal symptoms (time frame: 09/2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01074320, which also lists 1 linked publication.
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 16 Dec 2015.