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


N/A
18 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

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

Outcome Description:

unit of measure:ml/kg/min

Outcome Time Frame:

at 12 months

Safety Issue:

No

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

I12007

NCT ID:

NCT01795612

Start Date:

March 2013

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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