Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer

Breast Cancer Clinical Trial

— SAPA  

Official title:

Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01322412
• Other study ID #: I10 009 / SAPA
• Status: Completed
• Start date: May 2011
• Est. completion date: July 2013

Study information

• Verified date: March 2011
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Locations

Country	Name	City	State
France	Limoges University Hospital	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

References & Publications (1)

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 cont — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme		27 weeks
Secondary	Assessment at 27 and 54 weeks between the 2 groups of muscle function.		54 weeks