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Completed

NCT Number: NCT01322412

Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer

Physical exercise has been identified as a major item of many chronic diseases and cancer rehabilitation.

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Limoges University Hospital

Limoges, 87042, France

About this study

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 absorption.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: 27 weeks

Secondary outcomes

  1. Assessment at 27 and 54 weeks between the 2 groups of muscle function.

    Time frame: 54 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: SAPA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 24, 2011
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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