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

18 Years
75 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

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

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.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

27 weeks

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Limoges


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

I10 009 / SAPA



Start Date:

April 2011

Completion Date:

June 2015

Related Keywords:

  • Breast Cancer
  • Adapted physical activity
  • breast cancer
  • Breast Neoplasms