Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os

Lung Cancer Clinical Trial

Official title:

Home Respiratory Rehabilitation in Patients With Lung Cancer Non-small Cell Advanced or Metastatic Treated With Oral Targeted Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03216863
• Other study ID #: 2014_61
• Secondary ID: 2015-A00468-41
• Status: Terminated
• Phase: N/A
• Start date: August 3, 2015
• Est. completion date: August 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Hôpital Calmette, CHRU	Lille
France	Hôpital privé La Louvière	Lille
France	Centre hospitalier Victor Provo	Roubaix

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home		At 8 weeks
Secondary	Functional Assessment of Cancer Therapy Lung standardized	measure the quality of life	Baseline and 8 weeks
Secondary	EORTC QLQ C-30 standardized version 3.0	Measure the quality of life	Baseline and 8 weeks
Secondary	Functional capacity	Exercise capacity with the six minutes walk test	Baseline and 8 weeks
Secondary	Respiratory capacity	measured by the spirometry	Baseline and 8 weeks
Secondary	Nutritional Risk Screening score	Nutritional state assessment by albumine and pre albumine dosage	Baseline and 8 weeks
Secondary	Body Mass Index		Baseline and 8 weeks
Secondary	Overall and progression-free survival		at 6 months