Clinical trial NCT01795612: Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase
Official title: Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2013-02-20
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test
timeFrame: at 12 months
Secondary outcomes:
measure: Exercise tolerance at 12 months (group A vs B)
timeFrame: at 12 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: University Hospital, Limoges
Study officials:
References:
citation: Vincent F, Deluche E, Bonis J, Leobon S, Antonini MT, Laval C, Favard F, Dobbels E, Lavau-Denes S, Labrunie A, Thuillier F, Venat L, Tubiana-Mathieu N. Home-Based Physical Activity in Patients With Breast Cancer: During and/or After Chemotherapy? Impact on Cardiorespiratory Fitness. A 3-Arm Randomized Controlled Trial (APAC). Integr Cancer Ther. 2020 Jan-Dec;19:1534735420969818. doi: 10.1177/1534735420969818.