Skip to content

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03216863
Enrollment
25
Registered
2017-07-13
Start date
2015-08-03
Completion date
2017-08-31
Last updated
2018-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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.

Interventions

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

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at homeAt 8 weeks

Secondary

MeasureTime frameDescription
EORTC QLQ C-30 standardized version 3.0Baseline and 8 weeksMeasure the quality of life
Functional capacityBaseline and 8 weeksExercise capacity with the six minutes walk test
Respiratory capacityBaseline and 8 weeksmeasured by the spirometry
Functional Assessment of Cancer Therapy Lung standardizedBaseline and 8 weeksmeasure the quality of life
Body Mass IndexBaseline and 8 weeks
Overall and progression-free survivalat 6 months
Nutritional Risk Screening scoreBaseline and 8 weeksNutritional state assessment by albumine and pre albumine dosage

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026