Clinical Trial Evaluating the Efficacy and Implementation of an Early Adapted Physical Activity to Prevent and Manage Aromatase Inhibitor-induced Musculoskeletal Pain in Breast Cancer (APIS)
APIS
Randomized Clinical Trial Evaluating the Efficacy and Implementation of an Early Adapted Physical Activity to Prevent and Manage Aromatase Inhibitor-induced Musculoskeletal Pain in Breast Cancer
1 other identifier
interventional
182
1 country
2
Brief Summary
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 implementation effectiveness of early personalized APA (Adapted Physical Activity) in preventing AIMSS. The hybrid design will support the development of sustainable, patient-centered interventions, potentially improving quality of life, adherence to AI therapy and long-term outcomes in breast cancer survivorship. Ancillary study (Groupement Hospitalier Nord, Hospices Civils de Lyon) The humero-scapulo-thoracic region is particularly exposed to functional alterations during the course of care of patients treated for breast cancer. In addition to the loss of strength and mobility associated with surgical and medical treatment, the shoulder can also be the site of pain due to AIMSS or PMDS (Post-Mastectomy Pain Syndrome). These pains are often studied separately, depending on the treatment, but few studies offer a global vision of the functional evolution of the shoulder throughout the course of care, enabling prevention and adjustment of management. It is also relevant to assume that early APA treatment could improve functional rehabilitation in this area. The aim of this study is therefore to evaluate the impact of an APA assessment and early referral to a personalized program (APIS protocol) on shoulder functionality, depending on the time of intervention in the therapeutic pathway.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jun 2026
Typical duration for not_applicable breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2025
CompletedFirst Posted
Study publicly available on registry
December 19, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2029
Study Completion
Last participant's last visit for all outcomes
August 1, 2029
May 11, 2026
May 1, 2026
3.2 years
September 26, 2025
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Score of most intense musculoskeletal pain
To analyze the impact of implementing a specific APA program, right from the start of treatment, on the prevalence of musculoskeletal pain experienced by patients treated for breast cancer with aromatase inhibitors (AI) after 6 months of hormone therapy (peak of symptoms). Musculoskeletal pain are measured using the Nordic-type questionnaire. This score is measured using the Nordic questionnaire, which includes a Numerical Rating Scale (NRS) for musculoskeletal pain ranging from 0 to 10: * 0 = no pain or discomfort * 10 = intolerable pain or discomfort A higher score reflects a more unfavorable clinical outcome.
6 months after introduction of hormone therapy
Secondary Outcomes (34)
Evolution of musculoskeletal pain intensity
From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Score of global pain
From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Evaluation of Quality of life
From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Fatigue
From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
Anxiety
From the initial phase to 6 months after the introduction of Aromatase Inhibitors.
- +29 more secondary outcomes
Study Arms (2)
Adapted Physical Activity started early (announcement)
EXPERIMENTALThe APA (Adapted Physical Activity) program is decided during the initial assessment.
Adapted Physical Activity begins at the start of hormone therapy (control group).
ACTIVE COMPARATORPatients will receive standard care. The personalized APA (Adapted Physical Activity) protocol will begin at the same time as hormone therapy. Hormone therapy is initiated at the end of primary treatment and continues during the survivorship care period.
Interventions
Adapted Physical Activity begins at the start of hormone therapy The total duration of the rehabilitation protocol is 12 weeks, with 2 one-hour sessions per week. The rehabilitation protocol chosen in this study is mixed, i.e. it combines : * Exercise training on ergocyclometer or treadmill * Flexibility and muscle-strengthening work supervised by a physiotherapist * Free work with the APA practitioner
The Adapted Physical Activity program is decided during the initial assessment. The total duration of the rehabilitation protocol is 12 weeks, with 2 one-hour sessions per week. The rehabilitation protocol chosen in this study is mixed, i.e. it combines : * Exercise training on ergocyclometer or treadmill * Flexibility and muscle-strengthening work supervised by a physiotherapist * Free work with the APA practitioner
Eligibility Criteria
You may qualify if:
- Quantitative study:
- Women aged 18 to 75
- Person with non-metastatic breast cancer
- positive for at least one hormone receptor
- Person treated with an Aromatase Inhibitor
- Person with the following treatment regimen: Surgery - radiotherapy - aromatase inhibitor hormone therapy or surgery - chemotherapy (neoadjuvant or adjuvant) +/- targeted therapy - +/- radiotherapy - aromatase inhibitor hormone therapy.
- Person affiliated to a social security scheme
- Person having signed a free and informed consent
- Qualitative study:
- For patients :
- Patient having given consent to participate in the APIS study
- Patient agreeing to participate in the qualitative study (box checked on the APIS informed consent form)
- Patient agreeing to the recording of the semi-directive interview
- For healthcare professionals :
- Person practicing within the Saint-Étienne University Hospital and the Croix-Rousse University Hospital as a surgeon, oncologist, radiotherapist, sports medicine physician, APA instructor, physiotherapist, head nurse, care coordinator nurse, or advanced practice nurse
- +8 more criteria
You may not qualify if:
- For all patients:
- Person deprived of liberty by judicial or administrative decision
- Person under psychiatric care (unstable pathology)
- Person of full age under legal protection (guardianship, curatorship)
- Person unable to receive sufficient information due to impaired higher functions, or insufficient command of the French language
- Person with absolute contraindications to physical exercise:
- Unstable angina
- Decompensated heart failure
- Complex ventricular rhythm disorders
- Uncontrolled severe arterial hypertension
- Pulmonary arterial hypertension (\> 60 mm Hg)
- Presence of large or pedunculated intracavitary thrombus
- Acute pericardial effusion
- Severe obstructive cardiomyopathy
- Tight and/or symptomatic aortic stenosis
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Service de Gynécologie-Obstétrique, Groupement Hospitalier Nord, Hospices Civils de Lyon
Lyon, 69317, France
Service de Chirurgie Gynécologie-Obstétrique,CHU Hôpital Nord
Saint-Priest-en-Jarez, 42270, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2025
First Posted
December 19, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
August 1, 2029
Study Completion (Estimated)
August 1, 2029
Last Updated
May 11, 2026
Record last verified: 2026-05