Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os

NCT03216863 | Terminated

• 2 other identifiers: 2014_612015-A00468-41
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home

  At 8 weeks

Secondary Outcomes (7)

• Functional Assessment of Cancer Therapy Lung standardized

  Baseline and 8 weeks

• EORTC QLQ C-30 standardized version 3.0

  Baseline and 8 weeks

• Functional capacity

  Baseline and 8 weeks

• Respiratory capacity

  Baseline and 8 weeks

• Nutritional Risk Screening score

  Baseline and 8 weeks

Study Arms (1)

8 weeks Respiratory rehabilitation

EXPERIMENTAL

Other: Respiratory rehabilitation

Interventions

Respiratory rehabilitation 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

8 weeks Respiratory rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with advanced or metastatic lung cancer
• Diagnosis of CP retained after multidisciplinary discussion of patient records

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (3)

Hôpital Calmette, CHRU

Lille, France

Location

Hôpital privé La Louvière

Lille, France

Location

Centre hospitalier Victor Provo

Roubaix, France

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Arnaud Scherpereel, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 13, 2017
• Study Start: August 3, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 16, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)