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Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os

Primary Purpose

Lung Cancer

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Respiratory rehabilitation
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lung Cancer

Eligibility Criteria

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

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

Sites / Locations

  • Hôpital Calmette, CHRU
  • Hôpital privé La Louvière
  • Centre hospitalier Victor Provo

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

8 weeks Respiratory rehabilitation

Arm Description

Outcomes

Primary Outcome Measures

Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home

Secondary Outcome Measures

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

Full Information

First Posted
July 11, 2017
Last Updated
May 15, 2018
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03216863
Brief Title
Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os
Official Title
Home Respiratory Rehabilitation in Patients With Lung Cancer Non-small Cell Advanced or Metastatic Treated With Oral Targeted Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Study Start Date
August 3, 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients with advanced or metastatic non-small cell lung cancer treated with oral targeted therapy (tyrosine kinase (TKI) inhibitors of EGF-R and ALK inhibitors), regardless of the treatment line.
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
8 weeks Respiratory rehabilitation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Respiratory rehabilitation
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home
Time Frame
At 8 weeks
Secondary Outcome Measure Information:
Title
Functional Assessment of Cancer Therapy Lung standardized
Description
measure the quality of life
Time Frame
Baseline and 8 weeks
Title
EORTC QLQ C-30 standardized version 3.0
Description
Measure the quality of life
Time Frame
Baseline and 8 weeks
Title
Functional capacity
Description
Exercise capacity with the six minutes walk test
Time Frame
Baseline and 8 weeks
Title
Respiratory capacity
Description
measured by the spirometry
Time Frame
Baseline and 8 weeks
Title
Nutritional Risk Screening score
Description
Nutritional state assessment by albumine and pre albumine dosage
Time Frame
Baseline and 8 weeks
Title
Body Mass Index
Time Frame
Baseline and 8 weeks
Title
Overall and progression-free survival
Time Frame
at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnaud Scherpereel, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Calmette, CHRU
City
Lille
Country
France
Facility Name
Hôpital privé La Louvière
City
Lille
Country
France
Facility Name
Centre hospitalier Victor Provo
City
Roubaix
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os

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