Adapted Physical Activity Effect on Aerobic Function and... | NCT01795612

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

NCT01795612

Sponsor

University Hospital, Limoges

Status

Completed

Last Update Posted

Jan 15, 2019Actual

Enrollment

94Actual

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

physical activity

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013Actual

Primary Completion Date

May 2016Actual

Completion Date

Dec 2017Actual

First Submitted Date

Feb 18, 2013

First Submission Date that Met QC Criteria

Feb 18, 2013

First Posted Date

Feb 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2019

Last Update Posted Date

Jan 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

94Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm A	Other	6-month ETP, during adjuvant or neoadjuvant therapy	Other: physical activity
Arm B	Other	6-month ETP, after adjuvant or neoadjuvant therapy	Other: physical activity
Arm C	Other	12-monthETP, during and after adjuvant or neoadjuvant treatment	Other: physical activity

Interventions

Name	Type	Description	Arm Group Labels	Other Names
physical activity	Other		Arm A Arm B Arm C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Limoges		Limoges		87042	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33228382	Derived	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena