Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os

May 15, 2018 updated by: University Hospital, Lille

Home Respiratory Rehabilitation in Patients With Lung Cancer Non-small Cell Advanced or Metastatic Treated With Oral Targeted Therapy

The feasibility and impact of respiratory rehabilitation (RR) in patients with advanced or metastatic (EGF-R WT or mutated) non-small cell lung cancer treated with oral targeted therapy including Inhibitors of EGF-R tyrosine kinases (TKI) and ALK inhibitors.

These patients will benefit, at the beginning of the chemotherapy whatever the treatment line, of a respiratory rehabilitation. The respiratory rehabilitation takes place at the patient's home with the HAD's cooperation 3 hours per week, divided into 2 or 3 sessions. There is associated educational, nutritional and psychological support for a total duration of 8 weeks.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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

      • Lille, France
        • Hôpital Calmette, CHRU
      • Lille, France
        • Hôpital Privé La Louvière
      • Roubaix, France
        • Centre hospitalier Victor Provo

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with advanced or metastatic lung cancer
  • In the course of treatment by oral chemotherapy of oral targeted therapy (tyrosine kinase inhibitor) in 1st, 2nd, 3rd line or more at the time of their inclusion
  • Diagnosis of CP retained after multidisciplinary discussion of patient records

Exclusion Criteria:

  • Any residual toxicity of a previous antineoplastic treatment, grade> 2.
  • Cardio-respiratory contraindications to exercise re-training:
  • Angina unstable
  • Recent infarct
  • Tight aortic stenosis
  • Unsteady heart failure
  • Pericarditis, endocarditis, myocarditis
  • Evolutionary thromboembolic disease
  • Ventricular aneurysm
  • Intra ventricular thrombus
  • Uncontrolled rhythm disorders
  • Instability of the respiratory state defined by uncompensated respiratory acidosis
  • Carcinological contraindications:
  • Bone metastases at risk of fracture and / or algae despite optimal analgesic treatment, symptomatic central nervous system metastases
  • Presence of anemia (Hb <8g / dl or <10g / dl if patient with previous cardiac history), thrombocytopenia (<100,000 platelets / mm3)
  • Chimio toxicity (neurological, cardiac) according to the investigator's assessment
  • Neuromuscular contraindications:
  • Neuromuscular and / or osteo-articular disease making it impossible to re-train
  • Severe cognitive impairment
  • Patient under tutorship or curatorship

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 8 weeks Respiratory rehabilitation
It consists of a global care of the patient: therapeutic education, nutritional maintenance, psychological support and re-training to the effort at home after discharge or after follow up visit of targeted therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home
Time Frame: At 8 weeks
At 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Assessment of Cancer Therapy Lung standardized
Time Frame: Baseline and 8 weeks
measure the quality of life
Baseline and 8 weeks
EORTC QLQ C-30 standardized version 3.0
Time Frame: Baseline and 8 weeks
Measure the quality of life
Baseline and 8 weeks
Functional capacity
Time Frame: Baseline and 8 weeks
Exercise capacity with the six minutes walk test
Baseline and 8 weeks
Respiratory capacity
Time Frame: Baseline and 8 weeks
measured by the spirometry
Baseline and 8 weeks
Nutritional Risk Screening score
Time Frame: Baseline and 8 weeks
Nutritional state assessment by albumine and pre albumine dosage
Baseline and 8 weeks
Body Mass Index
Time Frame: Baseline and 8 weeks
Baseline and 8 weeks
Overall and progression-free survival
Time Frame: at 6 months
at 6 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Arnaud Scherpereel, MD, PhD, University Hospital, Lille

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)

August 3, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 15, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2014_61
  • 2015-A00468-41 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

Clinical Trials on Lung Cancer

Clinical Trials on Respiratory rehabilitation

3
Subscribe