Adapted Physical Activity Effect and Fatigue in Patients With Breast Cancer

NCT ID: NCT01322412

Last Updated: 2018-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-07-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

Arm B : conventional management

Arm B : conventional management during and after treatment

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent FRANCOIS, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Limoges

Locations

Limoges University Hospital

Limoges, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 25986222 (View on PubMed)

Other Identifiers

I10 009 / SAPA

Identifier Type: -

Identifier Source: org_study_id