NCT05949983 Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer
| NCT ID | NCT05949983 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Breast Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 866 participants |
| Start Date | 2024-12-23 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 866 participants in total. It began in 2024-12-23 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Adapted physical activity (APA) was recognized as a non-drug therapy by the French Health Authority (HAS) in 2011. Very few studies have examined the efficiency of APA programs during the active phase of treatment in cancer patients. The investigators assumed that non-drug therapy such as APA could improve the quality of life and reduces health costs. The main objective of this study is to assess the efficiency of a standardized APA program, as compared to conventional management including simple recommendations for the practice of physical activity in women in phase active breast cancer treatment.
Eligibility Criteria
Inclusion Criteria: * women with breast cancer * any type of breast cancer, all grades, all stages * during treatment: surgery +/- chemotherapy +/- radiotherapy +/- hormone therapy Exclusion Criteria: * World Health Organization (WHO) 4 * Unstable angina * Uncontrolled Atrial fibrillation * Uncontrolled high blood pressure * Recent myocardial infarction or myocarditis or pericarditis or thromboembolic disease (less than 3 weeks) * Aortic stenosis or valve disease to operate * Cardiac or respiratory failure, with dyspnea at rest * Symptomatic anemia, thrombocytopenia * Lytic or painful bone metastases, Severe osteoporosis * Severe infectious syndrome, * Surgery in the last 3 weeks * Extreme fatigue, sharp pain, dizziness, disturbance of consciousness, severe undernutrition * Contraindication to the practice of an adapted physical activity programme * Currently involved or exclusion period of a interventional study or adapted Physical Activity program * Patient with protective measures (guardianship, curators, and deprivation of liberty). * Pregnancy or breastfeeding * Patient with severe functional limitations
Contact & Investigator
Marie-Eve Rougé-Bugat, MD
PRINCIPAL INVESTIGATOR
University Toulouse
Frequently Asked Questions
Who can join the NCT05949983 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05949983 currently recruiting?
Yes, NCT05949983 is actively recruiting participants. Contact the research team at marieeve.rouge-bugat@dumg-toulouse.fr for enrollment information.
Where is the NCT05949983 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT05949983 clinical trial?
NCT05949983 is sponsored by University Hospital, Toulouse. The principal investigator is Marie-Eve Rougé-Bugat, MD at University Toulouse. The trial plans to enroll 866 participants.