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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital, Limoges

Limoges, 87042, France

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 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.

Treatment and study plan

Physical activity

Other

Primary outcomes

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 outcomes

Exercise tolerance at 12 months (group A vs B)

Time frame: at 12 months

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Acronym: APAC

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2017
First posted: Feb 20, 2013
Registry last updated: Jan 15, 2019

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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