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

January 11, 2019 updated by: University Hospital, Limoges
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • University Hospital, Limoges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm A
6-month ETP, during adjuvant or neoadjuvant therapy
Other: physical activity
Other: Arm B
6-month ETP, after adjuvant or neoadjuvant therapy
Other: physical activity
Other: Arm C
12-monthETP, during and after adjuvant or neoadjuvant treatment
Other: physical activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test
Time Frame: at 12 months
unit of measure:ml/kg/min
at 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Exercise tolerance at 12 months (group A vs B)
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

February 18, 2013

First Submitted That Met QC Criteria

February 18, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I12007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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