Multimodal Prehabilitation in Patients with Lung Cancer Undergoing Neoadjuvant Therapy

Trial Title: Multimodal Prehabilitation in Patients with Lung Cancer Undergoing Neoadjuvant Therapy

NCT ID: NCT05636969

Condition: Non Small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Masking description: Assessors will be blinded to the allocation of patients for some outcome measures (complications, neoadjuvant-related outcomes). Researchers conducting analyses will be blinded to patient allocation.

Intervention:

Intervention type: Behavioral
Intervention name: Multimodal prehabilitation
Description: The multimodal prehabilitation programme will consist of 1) twice weekly, supervised exercise training at the hospital gym for approximately 12-16 weeks; 2) nutritional consultation and diet optimization and supplementation if needed; 3) individual or group-based psychological support.
Arm group label: Prehabilitation

Summary: Neoadjuvant therapy (NAT) is currently indicated for patients with locoregional advanced non-small cell lung cancer (NSCLC) prior to resection surgery, but literature has suggest that this is associated with decreased pulmonary function and potentially cardiorespiratory fitness, leading to an 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 LRS versus standard of care (no prehabilitation); 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, controlled, non-randomized clinical trial including all patients with NSCLC scheduled for NAT at a tertiary hospital five hospitals across 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 assigned to the intervention based on geographical locations. Patients from hospitals were a multimodal prehabilitation is already running as part of standard of care, will be offer to participate in a supervised, multimodal exercise, nutrition and psychological programme during NAT (intervention group); those whose treatment will take place in a hospital where multimodal prehabilitation is not part of the model of care will be assigned to the control group and will only receive general recommendations. Patients will be assessed at baseline, after NAT and post-surgery.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Hospital Clinic de Barcelona

Address:
City: Barcelona
Zip: 08036
Country: Spain

Status: Recruiting

Contact:
Last name: Raquel Sebio, PhD

Start date: June 10, 2023

Completion date: June 1, 2027

Lead sponsor:
Agency: Hospital Clinic of Barcelona
Agency class: Other

Collaborator:
Agency: Fundació Sanitaria de Mollet
Agency class: Other

Collaborator:
Agency: Hospital General de Granollers
Agency class: Other

Collaborator:
Agency: Consorci Hospitalari de Vic
Agency class: Other

Source: Hospital Clinic of Barcelona

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05636969