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Completed

NCT Number: NCT01074320

Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

North Memorial Medical Center, Robbinsdale, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

other

Other

Observational study

Primary outcomes

  1. Identify a core set of instruments for measuring musculoskeletal symptoms

    Time frame: 09/2011

Secondary outcomes

  1. Model the time course and predictors of change in musculoskeletal symptoms

    Time frame: 09/2011

  2. Explore the effects of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment

    Time frame: 09/2011

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Acronym: AIMS

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Feb 24, 2010
Registry last updated
Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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