Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os

NCT ID: NCT03216863

Last Updated: 2018-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-03

Study Completion Date

2017-08-31

Brief Summary

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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

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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8 weeks Respiratory rehabilitation

Group Type EXPERIMENTAL

Respiratory rehabilitation

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud Scherpereel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Calmette, CHRU

Lille, , France

Site Status

Hôpital privé La Louvière

Lille, , France

Site Status

Centre hospitalier Victor Provo

Roubaix, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00468-41

Identifier Type: OTHER

Identifier Source: secondary_id

2014_61

Identifier Type: -

Identifier Source: org_study_id

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