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Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer (Rexochir)

Primary Purpose

Lungcancer

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
preoperative chest physiotherapy
preoperative rehabilitation program
Sponsored by
Centre Jean Perrin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lungcancer focused on measuring preoperative rehabilitation program, chest physiotherapy, lung cancer resection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients diagnosed for lung cancer (or highly suspicious for cancer tumor) eligible for resection surgery (lobectomy or pneumonectomy)
  • Age > 18 years
  • Presence of Chronic Obstructive Pulmonary Disease (COPD) stages 2-4 of Gold (forced expiratory volume (FEV )/ forced vital capacity (FVC) <70%, FEV <80% of predicted) and Exertional dyspnea stage MMRC (Medical Research Council) > 1
  • Patients must provide written consent
  • Member of social security scheme

Exclusion Criteria:

  • Patients refusing to participate
  • COPD stage 1 Gold (VEMS >= 80% of the theoretical value)
  • Presenting an operating contraindication during the initial maximal exercise test
  • Presenting cardiac or vascular contraindication to achieve the readaptation program
  • Patient living alone at home
  • Patient with ventilatory assistance at home (oxygen therapy or noninvasive ventilation (NIV))
  • With exercise hypoventilation (PaCO2 >45 mmHg)
  • Cognitive difficulty
  • unable major
  • pregnancy,
  • patients deprived of liberty by a court or administrative decision

Sites / Locations

  • CHU Clermont Ferrand, Gabriel Montpied, service de médecine du sport et explorations fonctionnelles,
  • Centre de Recherche en Nutrition Humaine
  • Centre Jean PerrinRecruiting
  • CHU Grenoble, Hôpital Michallon
  • Hospices Civiles de Lyon, groupement hospitalier Est, Hopital Louis Pradel
  • CHU Saint-Etienne, CHU Hopital Nord

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control group (C group)

rehabilitation group (R group)

Arm Description

patient will receive preoperative chest physiotherapy (standard supportive care)

patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training)

Outcomes

Primary Outcome Measures

Hospital length of stay after resection for lung cancer
the date of discharge will be the real day of discharge from surgery department or the day where the patient will be medically considered as outgoing

Secondary Outcome Measures

the number of complications
peak oxygen consumption
evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
6 minutes walking distance
evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
maximal voluntary quadriceps strength
evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
maximal inspiratory and expiratory strength
evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
real length of stay
the real day of discharge from surgery department
body composition (bioimpedancemetry)
evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
oxidative adaptations of the muscle
optional ancillary study on quadricipal and intercostal muscle biopsies.

Full Information

First Posted
December 20, 2016
Last Updated
February 17, 2023
Sponsor
Centre Jean Perrin
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1. Study Identification

Unique Protocol Identification Number
NCT03020251
Brief Title
Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer
Acronym
Rexochir
Official Title
Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2017 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized controlled trial will evaluate the effect of a preoperative rehabilitation program at home in patients resected for lung cancer, comparing a control group (C group) receiving only chest physiotherapy and a rehabilitation group (R group) receiving both a training program at home and chest physiotherapy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lungcancer
Keywords
preoperative rehabilitation program, chest physiotherapy, lung cancer resection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group (C group)
Arm Type
Active Comparator
Arm Description
patient will receive preoperative chest physiotherapy (standard supportive care)
Arm Title
rehabilitation group (R group)
Arm Type
Experimental
Arm Description
patient will receive preoperative chest physiotherapy and a preoperative rehabilitation program at home (exercise training)
Intervention Type
Other
Intervention Name(s)
preoperative chest physiotherapy
Intervention Description
preoperative chest physiotherapy : 5 sessions per week during 3 weeks
Intervention Type
Other
Intervention Name(s)
preoperative rehabilitation program
Intervention Description
exercise training at home : 5 sessions per week during 3 weeks
Primary Outcome Measure Information:
Title
Hospital length of stay after resection for lung cancer
Description
the date of discharge will be the real day of discharge from surgery department or the day where the patient will be medically considered as outgoing
Time Frame
time from the date of the surgery (Day 0) until the date of discharge (Day n) (assessed up to 56 days)
Secondary Outcome Measure Information:
Title
the number of complications
Time Frame
during the stay in the surgery department or the intensive care unit (up to 56 days)
Title
peak oxygen consumption
Description
evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
Time Frame
evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)
Title
6 minutes walking distance
Description
evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
Time Frame
evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)
Title
maximal voluntary quadriceps strength
Description
evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
Time Frame
evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)
Title
maximal inspiratory and expiratory strength
Description
evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
Time Frame
evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)
Title
real length of stay
Description
the real day of discharge from surgery department
Time Frame
between the first postoperative day (Day 1) and the real discharge date (up to 56 days)
Title
body composition (bioimpedancemetry)
Description
evaluation N°1 before intervention : during the week before the first date of the intervention (week 1) (intervention : preoperative chest physiotherapy +/- rehabilitation program will be realized on weeks 2, 3, and 4). evaluation N°2 after intervention and before surgery : during the week before the date of surgery (week 5)
Time Frame
evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2: during the week before the date of surgery (week 5)
Title
oxidative adaptations of the muscle
Description
optional ancillary study on quadricipal and intercostal muscle biopsies.
Time Frame
evaluation N°1 : during the week before the first date of the intervention (week 1). evaluation N°2 after intervention : at the date of surgery (during the surgical time at Day 0 week 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed for lung cancer (or highly suspicious for cancer tumor) eligible for resection surgery (lobectomy or pneumonectomy) Age > 18 years Presence of Chronic Obstructive Pulmonary Disease (COPD) stages 2-4 of Gold (forced expiratory volume (FEV )/ forced vital capacity (FVC) <70%, FEV <80% of predicted) and Exertional dyspnea stage MMRC (Medical Research Council) > 1 Patients must provide written consent Member of social security scheme Exclusion Criteria: Patients refusing to participate COPD stage 1 Gold (VEMS >= 80% of the theoretical value) Presenting an operating contraindication during the initial maximal exercise test Presenting cardiac or vascular contraindication to achieve the readaptation program Patient living alone at home Patient with ventilatory assistance at home (oxygen therapy or noninvasive ventilation (NIV)) With exercise hypoventilation (PaCO2 >45 mmHg) Cognitive difficulty unable major pregnancy, patients deprived of liberty by a court or administrative decision
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc FILAIRE, Pr
Phone
33473278121
Email
marc.filaire@clermont.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc FILAIRE, Pr
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont Ferrand, Gabriel Montpied, service de médecine du sport et explorations fonctionnelles,
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Coste, MD
First Name & Middle Initial & Last Name & Degree
Frédéric Costes
Facility Name
Centre de Recherche en Nutrition Humaine
City
Clermont-Ferrand
ZIP/Postal Code
63009
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruddy Richard, Pr
First Name & Middle Initial & Last Name & Degree
Ruddy Richard, Pr
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Filaire, Pr
Phone
33 (0) 4 73 27 53 11
Email
marc.filaire@cjp.fr
First Name & Middle Initial & Last Name & Degree
Marc Filaire, Pr
Facility Name
CHU Grenoble, Hôpital Michallon
City
Grenoble
ZIP/Postal Code
38700
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yves Brichon, Pr
First Name & Middle Initial & Last Name & Degree
Yves Brichon, Pr
Facility Name
Hospices Civiles de Lyon, groupement hospitalier Est, Hopital Louis Pradel
City
Lyon
ZIP/Postal Code
69677
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Tronc, Pr
First Name & Middle Initial & Last Name & Degree
François Tronc, Pr
Facility Name
CHU Saint-Etienne, CHU Hopital Nord
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivier Tiffet, Pr
First Name & Middle Initial & Last Name & Degree
Olivier Tiffet, Pr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29133320
Citation
Laurent H, Galvaing G, Thivat E, Coudeyre E, Aubreton S, Richard R, Kwiatkowski F, Costes F, Filaire M. Effect of an intensive 3-week preoperative home rehabilitation programme in patients with chronic obstructive pulmonary disease eligible for lung cancer surgery: a multicentre randomised controlled trial. BMJ Open. 2017 Nov 12;7(11):e017307. doi: 10.1136/bmjopen-2017-017307.
Results Reference
derived

Learn more about this trial

Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer

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