Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors

Completed

• Conditions: Breast Cancer
• Interventions: Other: Other

• Registration Number: NCT01074320
• Lead Sponsor: HealthPartners Institute

Brief 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. 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 Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Status Verified: 2015-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Last Update Submitted: 2015-12-15
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer patients on AIs	Other	Breast cancer patients beginning Aromatase Inhibitor therapy

Primary Outcome Measures

Name	Time	Method
Identify a core set of instruments for measuring musculoskeletal symptoms	09/2011

Secondary Outcome Measures

Name	Time	Method
Explore the effects of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment	09/2011
Model the time course and predictors of change in musculoskeletal symptoms	09/2011

Trial Locations

Locations (2)

Park Nicollet Institute; 🇺🇸 St. Louis Park, Minnesota, United States

North Memorial Medical Center; 🇺🇸 Robbinsdale, Minnesota, United States