Clinical trial · Observational
Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer
Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation. Therefore, physical activity for health is a valid and relevant way to improve quality of life and to manage cancer patient fatigue. The aim of the study is the assessment of the effects of a physical activity retraining program on aerobic capacity, strength and fatigue, in a breast cancer population treated by adjuvant chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Arm A : physical activity program
- description
- Arm A : physical activity program (aerobic and strength training) during the 27 weeks of treatment (chemotherapy and radiotherapy) and conventional follow-up during 27 weeks
- label
- Arm B : conventional management
- description
- Arm B : conventional management during and after treatment
Primary outcomes (1)
- measure
- main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme
- timeFrame
- 27 weeks
Secondary outcomes (1)
- measure
- Assessment at 27 and 54 weeks between the 2 groups of muscle function.
- timeFrame
- 54 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * females between 18 and 75 years of age * signed written informed consent * willing to take part in the trial and to follow the instructions * breast tumour, histologically documented * patients who have undergone curative surgery * patients for whom a 6-treatment course of adjuvant chemotherapy (3FEC100 + taxanes) and radiotherapy has been scheduled * patients with HER2-negative cancer. Exclusion Criteria: * metastatic cancer * other primary tumours * disability preventing a proper understanding of the instructions for the trial * chemotherapy strictly contra-indicated * patients who are subject to a court protection, wardship or guardianship order * uncontrolled hypertension * family history of sudden death in a first-degree relative * unstabilised heart disease * current treatment with beta-blockers * chronic or acute pulmonary disease associated with dyspnoea upon moderate effort * uncontrolled thyroid dysfunction * uncontrolled diabetes * any other serious conditions that are unstabilised, disabling or in which physical exercise is contra-indicated * unable to attend for follow-up throughout the duration of the study * ventricular ejection fraction (vef) \< 50%, pregnancy or suckling.
References
Publications (1)
- RESULTCornette T, Vincent F, Mandigout S, Antonini MT, Leobon S, Labrunie A, Venat L, Lavau-Denes S, Tubiana-Mathieu N. Effects of home-based exercise training on VO2 in breast cancer patients under adjuvant or neoadjuvant chemotherapy (SAPA): a randomized controlled trial. Eur J Phys Rehabil Med. 2016 Apr;52(2):223-32. Epub 2015 May 19. PMID 25986222