Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os

Not Applicable

Terminated

• Conditions: Lung Cancer

• Registration Number: NCT03216863
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-03
• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-13
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-15
• Last Update Posted: 2018-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home	At 8 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Hôpital Calmette, CHRU; 🇫🇷 Lille, France

Hôpital privé La Louvière; 🇫🇷 Lille, France

Centre hospitalier Victor Provo; 🇫🇷 Roubaix, France