Clinical trial · Observational
Measuring Musculoskeletal Symptoms in Patients Receiving Aromatase Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Other | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer patients on AIs
- description
- Breast cancer patients beginning Aromatase Inhibitor therapy
- interventionNames
- Other: Other
Primary outcomes (1)
- measure
- Identify a core set of instruments for measuring musculoskeletal symptoms
- timeFrame
- 09/2011
Secondary outcomes (2)
- measure
- Model the time course and predictors of change in musculoskeletal symptoms
- timeFrame
- 09/2011
- measure
- Explore the effects of musculoskeletal symptoms on adherence to AIs in women during the first 6 months of AI treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTSwenson 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 Forum. 2013 Nov;40(6):549-57. doi: 10.1188/13.ONF.549-557. PMID 24161633