Lung CancerNCT03216863
Home Respiratory Rehabilitation in Advanced Lung Cancer Chemotherapy Per os
A study testing Respiratory rehabilitation in people with Lung Cancer, run by University Hospital, Lille at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Respiratory rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesFrance
- Study dates
- 3 Aug 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Calmette, CHRU
Lille
Hôpital privé La Louvière
Lille
Centre hospitalier Victor Provo
Roubaix
About this study
Official title: Home Respiratory Rehabilitation in Patients With Lung Cancer Non-small Cell Advanced or Metastatic Treated With Oral Targeted Therapy
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
- Being tested
- Respiratory rehabilitation
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory rehabilitationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 8 weeks Respiratory rehabilitation | Experimental | Not described Receives: Other: Respiratory rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home
Measured: At 8 weeks
Secondary outcomes (7)
Functional Assessment of Cancer Therapy Lung standardized
measure the quality of life
Measured: Baseline and 8 weeks
EORTC QLQ C-30 standardized version 3.0
Measure the quality of life
Measured: Baseline and 8 weeks
Functional capacity
Exercise capacity with the six minutes walk test
Measured: Baseline and 8 weeks
Respiratory capacity
measured by the spirometry
Measured: Baseline and 8 weeks
Nutritional Risk Screening score
Nutritional state assessment by albumine and pre albumine dosage
Measured: Baseline and 8 weeks
Body Mass Index
Measured: Baseline and 8 weeks
Overall and progression-free survival
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start3 Aug 2015
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Scherpereel, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216863
- Sponsor's protocol ID
- 2014_61
- Other IDs
- 2015-A00468-41
- Status last verified
- May 2018
- First submitted
- 11 Jul 2017
- Last updated
- 16 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Respiratory Rehabilitation in Patients With Lung Cancer Non-small Cell Advanced or Metastatic Treated With Oral Targeted Therapy
- ClinicalTrials.gov ID
- NCT03216863
- Acronym / sponsor ID
- 2014_61
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 3 Aug 2015 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| 8 weeks Respiratory rehabilitation | Experimental | Other: Respiratory rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (20 listed)
- Any residual toxicity of a previous antineoplastic treatment, grade> 2.
- Cardio-respiratory contraindications to exercise re-training:
- Angina unstable
- Recent infarct
- Tight aortic stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory rehabilitationIt 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 | Other | 8 weeks Respiratory rehabilitation |
Primary outcome
Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home
Time frame: At 8 weeks
7 secondary outcomes
Functional Assessment of Cancer Therapy Lung standardized
Time frame: Baseline and 8 weeks
EORTC QLQ C-30 standardized version 3.0
Time frame: Baseline and 8 weeks
Functional capacity
Time frame: Baseline and 8 weeks
Respiratory capacity
Time frame: Baseline and 8 weeks
Nutritional Risk Screening score
Time frame: Baseline and 8 weeks
Body Mass Index
Time frame: Baseline and 8 weeks
Overall and progression-free survival
Time frame: at 6 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnaud Scherpereel, MD, PhD principal investigator
University Hospital, Lille
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory rehabilitation in people with Lung Cancer, run by University Hospital, Lille at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients completing the full Respiratory Rehabilitation (8 weeks) at home (time frame: At 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2018.