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)

Official record

Identifier

NCT07295457

Recruiting locations

country

France

Interventions studied

Adapted Physical Activity started earlyAdapted Physical Activity begins at the start of hormone therapy

Lead sponsor

Hospices Civils de Lyon

Target enrolment

182 participants

Study type

INTERVENTIONAL

Phase

Not applicable

Status

Recruiting

First posted

Dec 19, 2025

Last updated on the registry

Jul 31, 2026

Age

18 Years – 75 Years

Sex

FEMALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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