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Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors (AIMS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01074320
First Posted: February 24, 2010
Last Update Posted: December 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
HealthPartners Institute
  Purpose
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.

Condition Intervention
Breast Cancer Other: Other

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute:

Primary Outcome Measures:
  • Identify a core set of instruments for measuring musculoskeletal symptoms [ Time Frame: 09/2011 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 150
Study Start Date: February 2010
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast cancer patients on AIs
Breast cancer patients beginning Aromatase Inhibitor therapy
Other: Other
Observational study

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Post-menopausal breast cancer patients receiving aromatase inhibitors
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • History of rheumatoid arthritis,
  • Unable to read or understand English,
  • History of psychiatric disability affecting informed consent or compliance with study procedures.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01074320


Locations
United States, Minnesota
North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422
Park Nicollet Institute
St. Louis Park, Minnesota, United States, 55426
Sponsors and Collaborators
HealthPartners Institute
Investigators
Principal Investigator: Karen K Swenson, RN, PhD HealthPartners Institute
  More Information

Publications:
Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT01074320     History of Changes
Other Study ID Numbers: 03918-09
First Submitted: February 22, 2010
First Posted: February 24, 2010
Last Update Posted: December 16, 2015
Last Verified: August 2015

Keywords provided by HealthPartners Institute:
breast cancer
aromatase inhibitors
musculoskeletal symptoms

Additional relevant MeSH terms:
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs