- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03216863
Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Lille, France
- Hôpital Calmette, CHRU
-
Lille, France
- Hôpital Privé La Louvière
-
Roubaix, France
- Centre hospitalier Victor Provo
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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At 8 weeks
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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
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measured by the spirometry
|
Baseline and 8 weeks
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Nutritional Risk Screening score
Time Frame: Baseline and 8 weeks
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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
|
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Overall and progression-free survival
Time Frame: at 6 months
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at 6 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arnaud Scherpereel, MD, PhD, University Hospital, Lille
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
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.
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