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Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors (AIMS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Karen K Swenson, Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT01074320
First received: February 22, 2010
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  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
Breast Cancer

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:

U.S. FDA Resources

Further study details as provided by Park Nicollet Institute:

Primary Outcome Measures:
  • Identify a core set of instruments for measuring musculoskeletal symptoms [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Model the time course and predictors of change in musculoskeletal symptoms [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]
  • Explore the effects of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment [ Time Frame: 09/2011 ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: February 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Park Nicollet Institute
Investigators
Principal Investigator: Karen K Swenson, RN, PhD Park Nicollet Institute
  More Information

No publications provided

Responsible Party: Karen K Swenson, Research Scientist, Park Nicollet Institute
ClinicalTrials.gov Identifier: NCT01074320     History of Changes
Other Study ID Numbers: 03918-09
Study First Received: February 22, 2010
Last Updated: January 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Park Nicollet Institute:
breast cancer
aromatase inhibitors
musculoskeletal symptoms

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013