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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
physical activity
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital, Limoges

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Arm A

Arm B

Arm C

Arm Description

6-month ETP, during adjuvant or neoadjuvant therapy

6-month ETP, after adjuvant or neoadjuvant therapy

12-monthETP, during and after adjuvant or neoadjuvant treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Exercise tolerance at 12 months (group A vs B)

Full Information

First Posted
February 18, 2013
Last Updated
January 11, 2019
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT01795612
Brief Title
Adapted Physical Activity Effect on Aerobic Function and Fatigue at Home in Patients With Breast Cancer Treated in Adjuvant or Neoadjuvant Phase
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Other
Arm Description
6-month ETP, during adjuvant or neoadjuvant therapy
Arm Title
Arm B
Arm Type
Other
Arm Description
6-month ETP, after adjuvant or neoadjuvant therapy
Arm Title
Arm C
Arm Type
Other
Arm Description
12-monthETP, during and after adjuvant or neoadjuvant treatment
Intervention Type
Other
Intervention Name(s)
physical activity
Primary Outcome Measure Information:
Title
The main criterion is exercise tolerance at 12 months measured by VO2peak by incremental cardiopulmonary exercise test
Description
unit of measure:ml/kg/min
Time Frame
at 12 months
Secondary Outcome Measure Information:
Title
Exercise tolerance at 12 months (group A vs B)
Time Frame
at 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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.
Facility Information:
Facility Name
University Hospital, Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
33228382
Citation
Vincent F, Deluche E, Bonis J, Leobon S, Antonini MT, Laval C, Favard F, Dobbels E, Lavau-Denes S, Labrunie A, Thuillier F, Venat L, Tubiana-Mathieu N. Home-Based Physical Activity in Patients With Breast Cancer: During and/or After Chemotherapy? Impact on Cardiorespiratory Fitness. A 3-Arm Randomized Controlled Trial (APAC). Integr Cancer Ther. 2020 Jan-Dec;19:1534735420969818. doi: 10.1177/1534735420969818.
Results Reference
derived

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

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