Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase (APAC)

University of Limoges (UL)

Status: Completed

Conditions: Breast Cancer

Treatments: Other: physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT01795612

I12007

Details and patient eligibility

About

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.

Enrollment: 94 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 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 3 patient groups

Arm A

Other group

Description:

6-month ETP, during adjuvant or neoadjuvant therapy

Treatment:

Other: physical activity

Arm B

Other group

Description:

6-month ETP, after adjuvant or neoadjuvant therapy

Treatment:

Other: physical activity

Arm C

Other group

Description:

12-monthETP, during and after adjuvant or neoadjuvant treatment

Treatment:

Other: physical activity