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

Breast Cancer Clinical Trial

— APAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01795612
• Other study ID #: I12007
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: December 2017

Study information

• Verified date: September 2015
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 2017
• Est. primary completion date: May 2016
• 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 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Fatigue

Intervention

Other:
• physical activity

Locations

Country	Name	City	State
France	University Hospital, Limoges	Limoges

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test	unit of measure:ml/kg/min	at 12 months
Secondary	Exercise tolerance at 12 months (group A vs B)		at 12 months