Clinical trial NCT01322412: Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer
Official title: Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Adapted physical activity
breast cancer
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2011-03-24
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adjuvant breast cancer

Brief summary: 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.

Detailed 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.

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 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.

Primary outcomes:
measure: main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme
timeFrame: 27 weeks
Secondary outcomes:
measure: Assessment at 27 and 54 weeks between the 2 groups of muscle function.
timeFrame: 54 weeks
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges University Hospital
Study officials:
affiliation: University Hospital, Limoges
name: Vincent FRANCOIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cornette T, Vincent F, Mandigout S, Antonini MT, Leobon S, Labrunie A, Venat L, Lavau-Denes S, Tubiana-Mathieu N. Effects of home-based exercise training on VO2 in breast cancer patients under adjuvant or neoadjuvant chemotherapy (SAPA): a randomized controlled trial. Eur J Phys Rehabil Med. 2016 Apr;52(2):223-32. Epub 2015 May 19.