Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase

University Hospital, Limoges94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

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 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.

Outcomes

Primary Outcomes

The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test

unit of measure:ml/kg/min

Time frame: at 12 months

Secondary Outcomes

Exercise tolerance at 12 months (group A vs B)