Clinical trial NCT05636969: Multimodal Prehabilitation in Patients with Lung Cancer Undergoing Neoadjuvant Therapy
Official title: Effects of Multimodal Prehabilitation on Cardiorespiratory Fitness and Pulmonary Function During Neoadjuvant Therapy in Patients with Locally Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Small Cell Lung Cancer
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fundació Sanitaria de Mollet
name: Hospital General de Granollers
name: Consorci Hospitalari de Vic
name: CHU de Rouen - Accueil
First posted: 2022-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neoadjuvant therapy (NAT) with chemoimmunotherapy is currently indicated for patients with locoregional advanced non-small cell lung cancer (NSCLC) prior to resection surgery, but literature has suggested that this is associated with decreased pulmonary function and potentially cardiorespiratory fitness, leading to increased risk of postoperative complications. In this study, we aimed to: 1) compare the effects of NAT on cardiorespiratory fitness (VO2peak) and lung function (DLCO, FEV1 and FVC) in patients with locoregional lung cancer undergoing prehabilitation before lung resection surgery.

Secondary objectives included:

1. To determine feasibility of the intervention (recruitment rate, competition rate and adherence) as well as safety (incidence of adverse events), particularly regarding the exercise component;
2. To quantify the effects of the intervention in terms of functional capacity (1min Sit-to-Stand Test), mood (Hospital Anxiety and Depression Scale) and self-reported physical activity (Yale Physical Activity Survey).
3. To assess the effects of multimodal prehabilitation on treatment completion (dose reductions/delays in planning/treatment withdrawal) as well as tolerability/toxicity (Coming Terminology Criteria for Adverse Events version 4.03) to chemo/immunotherapy
4. To assess the effects of multimodal prehabilitation on surgical outcomes (postoperative complications based on the Comprehensive Complication Index (CCI) of the Clavien-Dindo Classification System and length of hospital stay).
5. To determine the effect of the intervention on post-operative functional recovery by means of the 1-min Sit-To-Stand test conducted at hospital discharge.

In order to achieve this, we will conduct a prospective study including all patients with NSCLC scheduled for NAT (chemoimmunotherapy or chemotherapy alone) across four different hospitals in Spain and France. Patients will be identified from the multidisciplinary tumour board and will be subsequently referred to the oncologist consultation. After this, one of the members of the researchers will contact the patient and explain the purpose of the study. Those who are willing to participate, will be scheduled to undergo a CardioPulmonary Exercise Test (CPET) in addition to standard lung function tests (spirometry, diffusion capacity of carbon monoxide). After that, patients will be invited to participate in a multimodal prehabilitation program including supervised exercise training, home-based inspiratory muscle training, nutritional optimization and psychological support. Patients who refuse participation in the program due to logistic reasons, will be asked to serve as controls. In addition, we will also use data from a historical cohort including patients treated with chemoimmunotherapy prior to the implementation of the study as controls.

Patients will be assessed at baseline, after NAT and post-surgery (at hospital discharge).


Eligibility criteria: Inclusion Criteria:

* Adult patients with diagnosed non-small celll lung cancer (NSCLC) undergoing neoadjuvant therapy before lung resection surgery

Exclusion Criteria:

* Physical impairments that prevent patients to perform a CardioPulmonary Exercise Test
* Non-resectable tumours
* Patients who refuse either surgical resection or neoadjuvant therapy

Primary outcomes:
measure: Changes in cardiorespiratory fitness assessed with a cardiopulmonary exercise test
timeFrame: 2 weeks post-neoadjuvant therapy
Secondary outcomes:
measure: Changes in diffusion capacity of carbon monoxide (DLCO)
timeFrame: 2 weeks post-neoadjuvant therapy
measure: Changes in submaximal cardiorespiratory fitness assessed with a cardiopulmonary exercise test
timeFrame: 2 weeks post-neoadjuvant therapy
measure: Changes in ventilatory efficiency (VE/VCO2 slope) assessed during a cardiopulmonary exercise test
timeFrame: 2 weeks post-neoadjuvant therapy
measure: Changes in pulmonary function (FEV1)
timeFrame: 2 weeks post-neoadjuvant therapy
measure: Changes in pulmonary function (FVC)
timeFrame: 2 weeks post-neoadjuvant therapy
measure: Feasibility (recruitment rate ) of multimodal prehabilitation
timeFrame: 1 week before surgery
measure: Feasibility (completion rate) of multimodal prehabilitation
timeFrame: 1 week before surgery
measure: Adherence
timeFrame: 1 week before surgery
measure: Adverse events
timeFrame: 1 week before surgery
measure: Postoperative Complications
timeFrame: within 30 days of hospital discharge
measure: 30-Day readmissions, re-interventions and emergency room visits
timeFrame: 30 days after surgery
measure: Chemoimmunotherapy completion rates
timeFrame: 1 week post-neoadjuvant therapy
measure: Post-surgery functional capacity
timeFrame: Same day as dicharge from hospital
measure: Post-NAT functional capacity
timeFrame: 2 weeks post-neoadjuvant therapy
measure: Post-NAT mood
timeFrame: 2 weeks post-neoadjuvant therapy
measure: Post-NAT self-reported physical activity
timeFrame: 2 weeks post-neoadjuvant therapy
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
References:
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