Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer (SAPA)

University of Limoges (UL)

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01322412

I10 009 / SAPA

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

44 participants in 2 patient groups

Arm A : physical activity program

Description:

Arm A : physical activity program (aerobic and strength training) during the 27 weeks of treatment (chemotherapy and radiotherapy) and conventional follow-up during 27 weeks

Arm B : conventional management

Description:

Arm B : conventional management during and after treatment