Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00468-41 | Other Identifier | ID-RCB number, ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 8 weeks Respiratory rehabilitation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Respiratory rehabilitation | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home | At 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Assessment of Cancer Therapy Lung standardized | measure the quality of life | Baseline and 8 weeks |
| EORTC QLQ C-30 standardized version 3.0 | Measure the quality of life |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Arnaud Scherpereel, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Calmette, CHRU | Lille | France | ||||
| Hôpital privé La Louvière |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Baseline and 8 weeks |
| Functional capacity | Exercise capacity with the six minutes walk test | Baseline and 8 weeks |
| Respiratory capacity | measured by the spirometry | Baseline and 8 weeks |
| Nutritional Risk Screening score | Nutritional state assessment by albumine and pre albumine dosage | Baseline and 8 weeks |
| Body Mass Index | Baseline and 8 weeks |
| Overall and progression-free survival | at 6 months |
| Lille |
| France |
| Centre hospitalier Victor Provo | Roubaix | France |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |