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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 (APAC)

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ClinicalTrials.gov Identifier: NCT01795612
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase
Actual Study Start Date : March 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Arm A
6-month ETP, during adjuvant or neoadjuvant therapy
Other: physical activity
Arm B
6-month ETP, after adjuvant or neoadjuvant therapy
Other: physical activity
Arm C
12-monthETP, during and after adjuvant or neoadjuvant treatment
Other: physical activity



Primary Outcome Measures :
  1. The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test [ Time Frame: at 12 months ]
    unit of measure:ml/kg/min


Secondary Outcome Measures :
  1. Exercise tolerance at 12 months (group A vs B) [ Time Frame: at 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01795612


Locations
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France
University Hospital, Limoges
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01795612    
Other Study ID Numbers: I12007
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: September 2015
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases