Aromatase inhibitor-associated musculoskeletal symptoms in breast cancer patients receiving adjuvant aromatase inhibitor Breast Neoplasms Aromatase Inhibitors Musculoskeletal Pain Exercise Therapy Home-Based Exercise
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients aged 18 years or more 2.Patients with pathologically confirmed early stage breast cancer. 3.Patients who are planned to receive aromatase inhibitor therapy for at least 2 years and who have initiated aromatase inhibitor treatment within the past 4 weeks. 4.Patients who are able to read and write and complete study questionnaires.
Exclusion criteria
Exclusion criteria: - Patients with inflammatory joint diseases requiring ongoing pharmacologic treatment. - Patients with ischemic heart disease or heart failure who have experienced chest pain or dyspnea within the past 6 months. - Patients who regularly engage in moderate-intensity or higher exercise, defined as 150 minutes per week or more - Patients who are deemed unable to comply with the study procedures after exercise assessment. - Patients who are unaware of their breast cancer diagnosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of aromatase inhibitor associated musculoskeletal symptoms (AIMSS) 12 months after randomization Percent | — |
Secondary
| Measure | Time frame |
|---|---|
| Characteristics and patterns of AIMSS in participants in both study groups. 12 months after randomization Location, Severity ,Proportion of participants with a clinically significant worsening of pain 3, 6, 9, and 12 months after randomization Defined as an increase of 2 or more points on the Numerical Rating Scale ,Body weight and physical fitness 3, 6, and 12 months after randomization rip strength, Timed Up and Go test, and 6-minute walk test,Quality of life 3, 6, 9, and 12 months after randomization Functional Assessment of Cancer Therapy Endocrine Symptoms questionnaire,Bone health 12 months after randomization bone mineral density T-score | — |
Countries
Thailand
Contacts
Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University