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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01322412
First received: March 23, 2011
Last updated: January 10, 2014
Last verified: March 2011
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Adapted Physical Activity Effect on Aerobic Function and Fatigue in Patients With Breast Cancer Treated in Adjuvant Phase

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • main criterion is exercise tolerance at 27 weeks, measured by VO2 max, following a physical activity (PA) programme [ Time Frame: 27 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment at 27 and 54 weeks between the 2 groups of muscle function. [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: May 2011
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Arm A : physical activity program
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
Arm B : conventional management during and after treatment

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

adjuvant breast cancer

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01322412

Locations
France
Limoges University Hospital
Limoges, France, 87042
Sponsors and Collaborators
University Hospital, Limoges
Investigators
Principal Investigator: Vincent FRANCOIS, MD University Hospital, Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01322412     History of Changes
Other Study ID Numbers: I10 009 / SAPA
Study First Received: March 23, 2011
Last Updated: January 10, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Limoges:
Adapted physical activity
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014