Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors

Breast Cancer Clinical Trial

— AIMS  

Official title:

Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074320
• Other study ID #: 03918-09
• Status: Completed
• Phase: N/A
• First received: February 22, 2010
• Last updated: December 15, 2015
• Start date: February 2010
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Other
Observational study

Locations

Country	Name	City	State
United States	North Memorial Medical Center	Robbinsdale	Minnesota
United States	Park Nicollet Institute	St. Louis Park	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Foru — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify a core set of instruments for measuring musculoskeletal symptoms		09/2011	No
Secondary	Model the time course and predictors of change in musculoskeletal symptoms		09/2011	No
Secondary	Explore the effects of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment		09/2011	No