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TerminatedNCT03216863Updated May 16, 2018

Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os

An interventional study of Respiratory rehabilitation in Lung Cancer, sponsored by University Hospital, Lille. Terminated at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-16.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Aug 2015, registered Jul 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Lung Cancer

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 25 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    8 weeks Respiratory rehabilitation

    Other: Respiratory rehabilitation

Interventions

  • OtherRespiratory 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

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What researchers measure

Primary outcomes

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

    Time frame: At 8 weeks

Secondary outcomes

  1. Functional Assessment of Cancer Therapy Lung standardized

    measure the quality of life

    Time frame: Baseline and 8 weeks

  2. EORTC QLQ C-30 standardized version 3.0

    Measure the quality of life

    Time frame: Baseline and 8 weeks

  3. Functional capacity

    Exercise capacity with the six minutes walk test

    Time frame: Baseline and 8 weeks

  4. Respiratory capacity

    measured by the spirometry

    Time frame: Baseline and 8 weeks

  5. Nutritional Risk Screening score

    Nutritional state assessment by albumine and pre albumine dosage

    Time frame: Baseline and 8 weeks

  6. Body Mass Index

    Time frame: Baseline and 8 weeks

  7. Overall and progression-free survival

    Time frame: at 6 months

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Study locations

3 sites
  • Hôpital Calmette, CHRU
    Lille, France
  • Hôpital privé La Louvière
    Lille, France
  • Centre hospitalier Victor Provo
    Roubaix, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03216863
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Jul 13, 2017
Start date
Aug 3, 2015
Primary completion
Aug 2017
Completion
Aug 2017
Last update
May 16, 2018

Study contacts

Arnaud Scherpereel, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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