Condition: Breast Cancer · Sponsor: Hospices Civils de Lyon
Aromatase inhibitors (AI) are the standard adjuvant hormone therapy for postmenopausal women with hormone-sensitive breast cancer. However, nearly half of patients experience AI-induced musculoskeletal symptoms (AIMSS), particularly pain, which compromise quality of life and treatment adherence. While adapted physical activity offers proven benefits in oncology, its specific role in preventing or managing AIMSS remains unclear. Moreover, the maintenance of physical activity during the care pathway in real-world settings is limited, highlighting the need for hybrid approaches that evaluate both clinical effectiveness and implementation. In response to these challenges, the primary study aim will be to compare the prevalence of musculoskeletal pain after six months of aromatase inhibitor therapy between patients initiating a personalized adapted physical activity program at the beginning of the care pathway and those receiving usual care. Secondary aims will be to (1) assess additional effects of the intervention on physical health, psychosocial well-being and treatment adherence, (2) explore contextual factors influencing program implementation in routine oncology care and (3) identify potential risk factors for the development of AIMSS. The APIS study is a hybrid type I effectiveness-implementation randomized controlled trial including 182 postmenopausal women with non-metastatic hormone-sensitive breast cancer. APIS will generate new evidence on the clinical and implementati…
This description comes directly from the study's public registry record.
Marion CORTET, MD · 472 071 936 · marion.cortet@chu-lyon.fr
Nathalie PIAZZON, Nurse · 472 071 266 · nathalie.piazzon@chu-lyon.fr
Always discuss trial participation with your own doctor first.
| Service de Gynécologie-Obstétrique, Groupement Hospitalier Nord, Hospices Civils de Lyon | Lyon, France | Recruiting |
| Service de Chirurgie Gynécologie-Obstétrique,CHU Hôpital Nord | Saint-Priest-en-Jarez, France | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07295457