Early Adapted Physical Activity to Prevent and Manage AI-induced Musculoskeletal Pain in Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines the effect of initiating a personalized adapted physical activity program at the beginning of aromatase inhibitor therapy in women with non-metastatic, hormone-receptor-positive breast cancer. The primary goal is to compare how common musculoskeletal pain is after six months of AI treatment between those starting the activity program early and those receiving usual care. Secondary goals include assessing additional clinical and implementation outcomes to understand feasibility and real-world adoption. The study includes both quantitative and qualitative components to capture patient experiences and provider perspectives across two Lyon-area hospitals. Participants are adults 18–75 affiliated with the social security system and meeting cancer and treatment criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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
* Persons working with patients treated with aromatase inhibitors for non-metastatic breast cancer
* Person who has received individual information
* Person who has given consent to participate in the study
* Person agreeing to the recording of the semi-directive interview
* Person of legal age

Ancillary study :

* Eligible patient who has given consent to participate in the APIS study
* Patient agreeing to participate in the ancillary study (box checked on the APIS informed consent form)

Exclusion Criteria:

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 participating in another interventional research study with an exclusion period still in progress at the time of pre-inclusion
* 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
  * Recent thrombophlebitis with or without pulmonary embolism
  * Diabetes with plantar perforator disease for physical activity activities involving the lower limbs
* Persons with musculoskeletal pathologies making cycling impossible

Where it's running

• 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

Study contacts

• Study coordinator: Marion CORTET, MD
• Email: marion.cortet@chu-lyon.fr
• Phone: 472 071 936

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.