Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Intervention
Name: physical activity
Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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.
Location
University Hospital, Limoges
Limoges, France
Status: Recruiting
Contact: Nicole TUBIANA-MATHIEU
Start Date
March 2013
Completion Date
December 2015
Sponsors
University Hospital, Limoges
Source
University Hospital, Limoges
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page