Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer

University Hospital, Limoges44 enrolled

Overview

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.

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 chemotherapy. A total of 44 subjects is required. The programme is organised as follows: Arm A (aerobic and strength training) and during the 27 weeks of treatment (chemotherapy and radiotherapy); Arm B (control group). This study includes 3 assessments phases (T0: before adjuvant chemotherapy; T1 (week 27) and T2: final evaluation at the 54th week). These assessments include: cardiopulmonary exercise test including maximal oxygen uptake test (VO2max), six-minute walk test, muscular testing, assessment of physical activity (IPAQ questionnaire), fatigue (MFI20 questionnaire), quality of life (EORTC QLQ C30), anxiety and depression symptoms (HADS) and nutritional evaluation: BMI and total body photonic absorption.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Limoges University Hospital

Limoges, France

Outcomes

Primary Outcomes

main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme

Time frame: 27 weeks

Secondary Outcomes

Assessment at 27 and 54 weeks between the 2 groups of muscle function.

Time frame: 54 weeks

Data from ClinicalTrials.gov

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