BridgeMD
Tests treatment safety and results for Breast Cancer
Official title 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)
ClinicalTrials.gov ID: NCT07295457
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join 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
You likely can't join 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 participating in another treatment research study with an exclusion period still in progress at the time of pre-inclusion
See the full eligibility 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...
- 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...
- 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)
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Lyon, France
- Saint-Priest-en-Jarez, France
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lyon, France; Saint-Priest-en-Jarez, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.