Clinical trial NCT03216863: 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
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home
timeFrame: At 8 weeks
Secondary outcomes:
measure: Functional Assessment of Cancer Therapy Lung standardized
timeFrame: Baseline and 8 weeks
measure: EORTC QLQ C-30 standardized version 3.0
timeFrame: Baseline and 8 weeks
measure: Functional capacity
timeFrame: Baseline and 8 weeks
measure: Respiratory capacity
timeFrame: Baseline and 8 weeks
measure: Nutritional Risk Screening score
timeFrame: Baseline and 8 weeks
measure: Body Mass Index
timeFrame: Baseline and 8 weeks
measure: Overall and progression-free survival
timeFrame: at 6 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Calmette, CHRU
city: Lille
country: France
facility: Hôpital privé La Louvière
city: Roubaix
country: France
facility: Centre hospitalier Victor Provo
Study officials:
affiliation: University Hospital, Lille
name: Arnaud Scherpereel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: