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

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01795612
• Lead Sponsor: University Hospital, Limoges

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-02-18
• Study First Submitted QC: 2013-02-18
• Study First Posted: 2013-02-20
• Study Start: 2013-03
• Status Verified: 2015-09
• Primary Completion: 2016-05
• Study Completion: 2017-12
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test	at 12 months	unit of measure:ml/kg/min

Secondary Outcome Measures

Name	Time	Method
Exercise tolerance at 12 months (group A vs B)	at 12 months

Trial Locations

Locations (1)

University Hospital, Limoges; 🇫🇷 Limoges, France