Clinical trial · Interventional
Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant 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. It contributes to an improvement in the quality of life and to a decrease in the current treatment side effects and mortality. Cancer in association with treatment toxicity and an inactive lifestyle lead to a fall in physical capability and causes problems in daily activities. The physical capacity and the tolerance for exercise fall simultaneously leading to a deconditioning vicious circle which increases physical, psychological and emotional symptoms of fatigue. 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 or néoadjuvant 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| physical activity | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- OTHER
- label
- Arm A
- description
- 6-month ETP, during adjuvant or neoadjuvant therapy
- interventionNames
- Other: physical activity
- type
- OTHER
- label
- Arm B
- description
- 6-month ETP, after adjuvant or neoadjuvant therapy
- interventionNames
- Other: physical activity
- type
- OTHER
- label
- Arm C
- description
- 12-monthETP, during and after adjuvant or neoadjuvant treatment
- interventionNames
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 for whom a 6-treatment course of adjuvant or neoadjuvant chemotherapy (3FEC100 +3 taxanes or 6 FEC) +/- radiotherapy+/- Herceptin has been scheduled; Exclusion Criteria: * metastatic cancer; * disability preventing a proper understanding of the instructions for the trial; * 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)
- DERIVEDVincent F, Deluche E, Bonis J, Leobon S, Antonini MT, Laval C, Favard F, Dobbels E, Lavau-Denes S, Labrunie A, Thuillier F, Venat L, Tubiana-Mathieu N. Home-Based Physical Activity in Patients With Breast Cancer: During and/or After Chemotherapy? Impact on Cardiorespiratory Fitness. A 3-Arm Randomized Controlled Trial (APAC). Integr Cancer Ther. 2020 Jan-Dec;19:1534735420969818. doi: 10.1177/1534735420969818. PMID 33228382