Non-Small Cell Lung CancerPreo-DensNCT03936764
Effect of Two Different Preoperative Training Densities in Patients With Non-small-cell Lung Cancer Before Lung Resection Surgery
A study testing Preoperative Pulmonary Rehabilitation in people with Non-Small Cell Lung Cancer, run by ADIR Association at 1 site in France.
Trial summary
Pulmonary resection surgery is currently the recommended curative treatment for early stages of non-small cell lung cancer. The implementation of preoperative respiratory rehabilitation programs has shown beneficial results on pulmonary function, functional level, cardiorespiratory conditioning and the occurrence and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Preoperative Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 7 May 2019to 16 Jun 2021
- 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
- Age> 18 years old;
- Beneficiary of a social security scheme;
- Non-Small Cell Lung Cancer or suspicion of bronchial neoplasia;
- Addressed to respiratory rehabilitation in a preoperative setting with a moderate to high risk estimate (VO2peak < 20 ml/kg/min);
- Intervention date not established when included in the program or ≥ 5 wk.
Who cannot join
- Patient under guardianship;
- Pregnant or lactating woman;
- Cardiological contraindication to training;
- Neoadjuvant radio-chemotherapy;
- Refusal to carry out a training program in a rehabilitation center;
- Orthopedic, neurological, vascular or neuromuscular pathology limiting training;
- Exacerbation or deterioration of the general condition requiring stopping the preoperative re-training program;
- Modification of the therapeutic project at a multidisciplinary consultation meeting requiring the cessation of rehabilitation or participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Pulmonary resection surgery is currently the recommended curative treatment for early stages of non-small cell lung cancer. The implementation of preoperative respiratory rehabilitation programs has shown beneficial results on pulmonary function, functional level, cardiorespiratory conditioning and the occurrence and severity of postoperative complications in this population of patients. Despite these benefits, the most recent meta-analyzes highlight the fact that training modalities (duration, frequencies, intensity) are very heterogeneous. It is then difficult to structure a program only on the basis of data from the literature.
In a cohort analysis of 50 patients trained from 2014 to 2017, our team reported a significantly greater improvement in physiological parameters in patients who performed 15 or more preoperative training sessions. This number of 15 outpatient sessions is therefore considered a minimum training goal in our current practice.
Read more
The difficulty of the oncological context is to find the compromise between the necessary diligence to initiate the cancer surgical treatment and the necessary time to obtain the benefits of the preoperative rehabilitation. Previous study reports the difficulty of setting up a four-week training program, perceived as delaying surgery. In order to prevent any risk of prolonging the surgical management time, rehabilitation teams routinely offer short programs with high training frequencies of up to five to six sessions per week. It seems important to note that preoperative rehabilitation is normally considered in patients for whom there is a risk of moderate to high postoperative complications according to the European and North American recommendations. Thus these patients generally benefit from a longer period of assessment than patients whose risk is considered low in terms of their cardio-respiratory and muscular function.
The median duration between the physiological evaluation of patients considered "at risk" before pulmonary resection surgery is 44 (Q1-Q3 29-76) days at Rouen University Hospital, with no significant differences observed between patients who have benefited or not from preoperative rehabilitation. Some teams have even pointed out that there is no difference in survival prognosis in the short or long term between patients who have had an operative delay of more or less 60 or 90 days respectively, which shows the compatibility with the set up a dedicated training course.
As mentioned earlier, the concept of delay has led to extremely dense training for a functionally and cardio-respiratory fragile target population as evidenced by pejorative VO2peak. The density of the training, failing to generate significant physiological stimulation, may increase fatigue or limit adherence to training, especially if it requires movement, and is added to a therapeutic planning including many consultations and further examinations. To date, no study has evaluated the density of preoperative supervised training on pre-surgical benefits.
The objective of this work is to compare the effectiveness of a program of 15 training sessions on VO2peak according to two different densities, namely five times a week over three weeks, or three times a week over five weeks.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Preoperative Pulmonary Rehabilitation
- Keywords
- NSCLC, Preoperative pulmonary rehabilitation, Preoperative training, Prehabilitation, Lung resection
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative Pulmonary RehabilitationOther
Each prehabilitation session will last approximately 90 minutes and will include:
- Endurance training at the ventilatory threshold, determined according to the initial CPET. The first session will last for 15 to 20 minutes then increase by 5 minutes each session to reach 45 minutes in total (including a 5-minute warm-up and 5 minutes of active recovery). The intensity will then increase by 5 or 10 W, as could be tolerated;
- Peripheral muscle strengthening at 60% to 70% of the 1-repetition maximum of 3 main components (quadriceps press, whole-leg extension, and upper limb pull down). Three sets of 12 movements will carry out for each exercise and the load will increase weekly as tolerated;
- Inspiratory muscle training using a threshold calibrated to at least 30% of the MIP. Patients will be encouraged to carry out 15 minutes of independent training daily and to increase the resistance regularly.
- Education to bronchial drainage techniques as well as directed coughing.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | 5 Preoperative Pulmonary Rehabilitation sessions / week during 3 weeks. Receives: Other: Preoperative Pulmonary Rehabilitation |
| Group 2 | Other | 3 Preoperative Pulmonary Rehabilitation sessions / week during 5 weeks. Receives: Other: Preoperative Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak dioxyen consumption (VO2peak)
VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)
Measured: before the preoperative training program
peak dioxyen consumption (VO2peak)
VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)
Measured: through preoperative training program completion (15 sessions)
Secondary outcomes (20)
peak work-rate (WRpeak)
maximum power reached during the Cardio-Pulmonary Exercise Testing (CPET)
Measured: before the preoperative training program
peak work-rate (WRpeak)
maximum power reached during the Cardio-Pulmonary Exercise Testing (CPET)
Measured: through preoperative training program completion (15 sessions)
oxygen consumption at ventilatory threshold (VO2vt)
oxygen consumption at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
Measured: before the preoperative training program
oxygen consumption at ventilatory threshold (VO2vt)
oxygen consumption at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
Measured: through preoperative training program completion (15 sessions)
work-rate at ventilatory threshold (WRvt)
work-rate at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
Measured: before the preoperative training program
work-rate at ventilatory threshold (WRvt)
work-rate at ventilatory threshold recorded during the Cardio-Pulmonary Exercise Testing (CPET)
Measured: through preoperative training program completion (15 sessions)
ventilatory efficiency (VE/VCO2 slope)
linear regression of the ratio between the increase in minute ventilation and the expired carbon dioxide flow (VE/VCO2 slope)
Measured: before the preoperative training program
ventilatory efficiency (VE/VCO2 slope)
linear regression of the ratio between the increase in minute ventilation and the expired carbon dioxide flow (VE/VCO2 slope)
Measured: through preoperative training program completion (15 sessions)
body mass index (BMI)
weight in kilograms divided by the square of height in meters
Measured: before the preoperative training program
body mass index (BMI)
weight in kilograms divided by the square of height in meters
Measured: through preoperative training program completion (15 sessions)
fat-free mass
impedancemetry (Bodystat® 1500MDD, (5/50 kHz), Bodystat, Douglas, Isle of Man, UK).
Measured: before the preoperative training program
fat-free mass
impedancemetry (Bodystat® 1500MDD, (5/50 kHz), Bodystat, Douglas, Isle of Man, UK).
Measured: through preoperative training program completion (15 sessions)
quadriceps peak torque
quadriceps peak torque (in Nm) assessed by dynamometry (MicroFET2®, Hogan Health Industries, Inc., UT)
Measured: before the preoperative training program
quadriceps peak torque
quadriceps peak torque (in Nm) assessed by dynamometry (MicroFET2®, Hogan Health Industries, Inc., UT)
Measured: through preoperative training program completion (15 sessions)
maximum inspiratory pressure (MIP)
Maximum negative oral pressure generated by the patient during inspiration (in cmH2O)
Measured: before the preoperative training program
maximum inspiratory pressure (MIP)
Maximum negative oral pressure generated by the patient during inspiration (in cmH2O)
Measured: through preoperative training program completion (15 sessions)
Health related quality of life (HRQoL) questionnaire
Full name of the scale : "European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire and modular supplement for Lung Cancer patients" (EORTC QLQ-C30 / LC13) The EORTC QLQ-C30, is a 30 questions questionnaire developed by the European Organization for Research and Treatment of Cancer, to assess the QoL of cancer patients. It has been translated and validated into over 100 languages and is used in more than 3,000 studies worldwide.
For patients with Lung Cancer, a 13 questions modular supplement, the LC-13, is validated.
The HRQoL is therefore evaluated by a set of 43 questions gathering all aspects that could be impacted.
A raw score is calculated for each dimension and summary score, then standardized from 0 to 100 points. The additional module for Lung Cancer (LC-13) provides a complementary dimension with specific items related to the tumor site.
(see Fayers et. al., The EORTC QLQ-C30 Scoring Manual (3rd Edition) 2001.
Measured: before the preoperative training program
Health related quality of life (HRQoL) questionnaire
Full name of the scale : "European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire and modular supplement for Lung Cancer patients" (EORTC QLQ-C30 / LC13) The EORTC QLQ-C30, is a 30 questions questionnaire developed by the European Organization for Research and Treatment of Cancer, to assess the QoL of cancer patients. It has been translated and validated into over 100 languages and is used in more than 3,000 studies worldwide.
For patients with Lung Cancer, a 13 questions modular supplement, the LC-13, is validated.
The HRQoL is therefore evaluated by a set of 43 questions gathering all aspects that could be impacted.
A raw score is calculated for each dimension and summary score, then standardized from 0 to 100 points. The additional module for Lung Cancer (LC-13) provides a complementary dimension with specific items related to the tumor site.
(see Fayers et. al., The EORTC QLQ-C30 Scoring Manual (3rd Edition) 2001.
Measured: through preoperative training program completion (15 sessions)
Adherence to sessions
number of sessions performed on number of sessions planned
Measured: through preoperative training program completion (15 sessions)
Postoperative Complications
number and type of complication during the 30 days post lung resection. Each complication severity is evaluated with the Clavien-Dindo scale.
Measured: At 30 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start7 May 2019
- Primary completion19 May 2021
- Study completion16 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936764
- Sponsor's protocol ID
- Preo-Dens
- Other IDs
- ID-RCB : 2018-A03301-54
- Acronym
- Preo-Dens
- Status last verified
- Aug 2021
- First submitted
- 30 Apr 2019
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gravier FE, Smondack P, Boujibar F, Prieur G, Medrinal C, Combret Y, Muir JF, Baste JM, Cuvelier A, Debeaumont D, Bonnevie T. Prehabilitation sessions can be provided more frequently in a shortened regimen with similar or better efficacy in people with non-small cell lung cancer: a randomised trial. J Physiother. 2022 Jan;68(1):43-50. doi: 10.1016/j.jphys.2021.12.010. Epub 2021 Dec 21.
PubMed 34952813
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two Different Preoperative Training Densities in Patients With Non-small-cell Lung Cancer Before Lung Resection Surgery
- ClinicalTrials.gov ID
- NCT03936764
- Acronym / sponsor ID
- Preo-Dens / Preo-Dens
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- NSCLC, Preoperative pulmonary rehabilitation, Preoperative training, Prehabilitation, Lung resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Study start
- 7 May 2019 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 16 Jun 2021 (actual)
- First posted
- 3 May 2019 (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.
Pulmonary resection surgery is currently the recommended curative treatment for early stages of non-small cell lung cancer. The implementation of preoperative respiratory rehabilitation programs has shown beneficial results on pulmonary function, functional level, cardiorespiratory conditioning and the occurrence and severity of postoperative complications in this population of patients. Despite these benefits, the most recent meta-analyzes highlight the fact that training modalities (duration, frequencies, intensity) are very heterogeneous. It is then difficult to structure a program only on the basis of data from the literature.
In a cohort analysis of 50 patients trained from 2014 to 2017, our team reported a significantly greater improvement in physiological parameters in patients who performed 15 or more preoperative training sessions. This number of 15 outpatient sessions is therefore considered a minimum training goal in our current practice.
The difficulty of the oncological context is to find the compromise between the necessary diligence to initiate the cancer surgical treatment and the necessary time to obtain the benefits of the preoperative rehabilitation. Previous study reports the difficulty of setting up a four-week training program, perceived as delaying surgery. In order to prevent any risk of prolonging the surgical management time, rehabilitation teams routinely offer short programs with high training frequencies of up to five to six sessions per week. It seems important to note that preoperative rehabilitation is normally considered in patients for whom there is a risk of moderate to high postoperative complications according to the European and North American recommendations. Thus these patients generally benefit from a longer period of assessment than patients whose risk is considered low in terms of their cardio-respiratory and muscular function.
The median duration between the physiological evaluation of patients considered "at risk" before pulmonary resection surgery is 44 (Q1-Q3 29-76) days at Rouen University Hospital, with no significant differences observed between patients who have benefited or not from preoperative rehabilitation. Some teams have even pointed out that there is no difference in survival prognosis in the short or long term between patients who have had an operative delay of more or less 60 or 90 days respectively, which shows the compatibility with the set up a dedicated training course.
As mentioned earlier, the concept of delay has led to extremely dense training for a functionally and cardio-respiratory fragile target population as evidenced by pejorative VO2peak. The density of the training, failing to generate significant physiological stimulation, may increase fatigue or limit adherence to training, especially if it requires movement, and is added to a therapeutic planning including many consultations and further examinations. To date, no study has evaluated the density of preoperative supervised training on pre-surgical benefits.
The objective of this work is to compare the effectiveness of a program of 15 training sessions on VO2peak according to two different densities, namely five times a week over three weeks, or three times a week over five weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Other: Preoperative Pulmonary Rehabilitation5 Preoperative Pulmonary Rehabilitation sessions / week during 3 weeks. |
| Group 2 | Other | Other: Preoperative Pulmonary Rehabilitation3 Preoperative Pulmonary Rehabilitation sessions / week during 5 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age> 18 years old;
- Beneficiary of a social security scheme;
- Non-Small Cell Lung Cancer or suspicion of bronchial neoplasia;
- Addressed to respiratory rehabilitation in a preoperative setting with a moderate to high risk estimate (VO2peak < 20 ml/kg/min);
- Intervention date not established when included in the program or ≥ 5 wk.
Key exclusion criteria (8 listed)
- Patient under guardianship;
- Pregnant or lactating woman;
- Cardiological contraindication to training;
- Neoadjuvant radio-chemotherapy;
- Refusal to carry out a training program in a rehabilitation center;
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 |
|---|---|---|
| Preoperative Pulmonary RehabilitationEach prehabilitation session will last approximately 90 minutes and will include: * Endurance training at the ventilatory threshold, determined according to the initial CPET. The first session will last for 15 to 20 minutes then increase by 5 minutes each session to reach 45 minutes in total (including a 5-minute warm-up and 5 minutes of active recovery). The intensity will then increase by 5 or 10 W, as could be tolerated; * Peripheral muscle strengthening at 60% to 70% of the 1-repetition maximum of 3 main components (quadriceps press, whole-leg extension, and upper limb pull down). Three sets of 12 movements will carry out for each exercise and the load will increase weekly as tolerated; * Inspiratory muscle training using a threshold calibrated to at least 30% of the MIP. Patients will be encouraged to carry out 15 minutes of independent training daily and to increase the resistance regularly. * Education to bronchial drainage techniques as well as directed coughing. | Other | Group 1, Group 2 |
Primary outcome
peak dioxyen consumption (VO2peak)
Time frame: before the preoperative training program
VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)
peak dioxyen consumption (VO2peak)
Time frame: through preoperative training program completion (15 sessions)
VO2peak (in ml/kg/min) measured during and incremental Cardio-Pulmonary Exercise Testing (CPET)
20 secondary outcomes
peak work-rate (WRpeak)
Time frame: before the preoperative training program
peak work-rate (WRpeak)
Time frame: through preoperative training program completion (15 sessions)
oxygen consumption at ventilatory threshold (VO2vt)
Time frame: before the preoperative training program
oxygen consumption at ventilatory threshold (VO2vt)
Time frame: through preoperative training program completion (15 sessions)
work-rate at ventilatory threshold (WRvt)
Time frame: before the preoperative training program
work-rate at ventilatory threshold (WRvt)
Time frame: through preoperative training program completion (15 sessions)
ventilatory efficiency (VE/VCO2 slope)
Time frame: before the preoperative training program
ventilatory efficiency (VE/VCO2 slope)
Time frame: through preoperative training program completion (15 sessions)
body mass index (BMI)
Time frame: before the preoperative training program
body mass index (BMI)
Time frame: through preoperative training program completion (15 sessions)
fat-free mass
Time frame: before the preoperative training program
fat-free mass
Time frame: through preoperative training program completion (15 sessions)
quadriceps peak torque
Time frame: before the preoperative training program
quadriceps peak torque
Time frame: through preoperative training program completion (15 sessions)
maximum inspiratory pressure (MIP)
Time frame: before the preoperative training program
maximum inspiratory pressure (MIP)
Time frame: through preoperative training program completion (15 sessions)
Health related quality of life (HRQoL) questionnaire
Time frame: before the preoperative training program
Health related quality of life (HRQoL) questionnaire
Time frame: through preoperative training program completion (15 sessions)
Adherence to sessions
Time frame: through preoperative training program completion (15 sessions)
Postoperative Complications
Time frame: At 30 days post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Derived from this study: PubMed 34952813Gravier FE, Smondack P, Boujibar F, Prieur G, Medrinal C, Combret Y, Muir JF, Baste JM, Cuvelier A, Debeaumont D, Bonnevie T. Prehabilitation sessions can be provided more frequently in a shortened regimen with similar or better efficacy in people with non-small cell lung cancer: a randomised trial. J Physiother. 2022 Jan;68(1):43-50. doi: 10.1016/j.jphys.2021.12.010. Epub 2021 Dec 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative Pulmonary Rehabilitation in people with Non-Small Cell Lung Cancer, run by ADIR Association at 1 site 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
peak dioxyen consumption (VO2peak) (time frame: before the preoperative training program). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03936764, which also lists 1 linked publication.
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 3 Aug 2021.