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Effectiveness of Tailored Home based Exercise on aromatase inhibitor associated musculoskeletal symptoms in breast cancer patients receiving adjuvant aromatase inhibitor

Effectiveness of Tailored Home based Exercise on aromatase inhibitor associated musculoskeletal symptoms in breast cancer patients receiving adjuvant aromatase inhibitor

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260208017
Enrollment
206
Registered
2026-02-08
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aromatase inhibitor-associated musculoskeletal symptoms in breast cancer patients receiving adjuvant aromatase inhibitor Breast Neoplasms Aromatase Inhibitors Musculoskeletal Pain Exercise Therapy Home-Based Exercise

Interventions

Participants in the intervention group or those enrolled in the TAILOR Ex program will meet with a sports medicine physician to receive exercise counseling, following the procedures outlined below - E
Tailored Home based Exercise ,Controlled

Sponsors

Routine to Research Unit, Faculty of Medicine Siriraj Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
Incidence of aromatase inhibitor associated musculoskeletal symptoms (AIMSS) 12 months after randomization Percent

Secondary

MeasureTime 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

Public ContactSuthinee Ithimakin

Division of Medical Oncology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University

aesi105@yahoo.co.th0898127440

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026