Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer

Lungcancer Clinical Trial

— Rexochir  

Official title:

Effects of Preoperative Rehabilitation in Patients Resected for Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03020251
• Other study ID #: 2016-A00622-49
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2017
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Centre Jean Perrin
• Contact: Marc FILAIRE, Pr
• Phone: 33473278121
• Email: marc.filaire[@]clermont.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Lungcancer

Intervention

Other:
• preoperative chest physiotherapy
preoperative chest physiotherapy : 5 sessions per week during 3 weeks
• preoperative rehabilitation program
exercise training at home : 5 sessions per week during 3 weeks

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time from the date of the surgery (Day 0) until the date of discharge (Day n) (assessed up to 56 days)
Secondary	the number of complications		during the stay in the surgery department or the intensive care unit (up to 56 days)
Secondary	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)	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)
Secondary	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)	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)
Secondary	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)	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)
Secondary	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)	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)
Secondary	real length of stay	the real day of discharge from surgery department	between the first postoperative day (Day 1) and the real discharge date (up to 56 days)
Secondary	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)	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)
Secondary	oxidative adaptations of the muscle	optional ancillary study on quadricipal and intercostal muscle biopsies.	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)