Status:
NOT_YET_RECRUITING
Athletic Intervention After THoracic surgEry for luNg cAncer: a Pilot Study
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Collaborating Sponsors:
Università degli Studi di Pavia
Conditions:
Non-small Cell Lung Cancer (NSCLC)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a pilot trial, monocentric interventional study that aims to investigate the results obtained by administering a specific athletic/physical protocol to a cohort of patients who undergo lung su...
Detailed Description
The aim of this pilot study is to assess in a preliminary cohort the effect of an active athletic training program in improving respiratory function parameters as well as quality of life after resecti...
Eligibility Criteria
Inclusion
- Male and female ≥18 years old
- Patient underwent a curative surgical treatment of NSCLC (stage IA according to AIOM guidelines, website https://www.iss.it/documents/20126/8403839/LG149\_Polmone\_agg2024.pdf/9e22916b-799c-3966-7dc9-01762112ce94?version=1.0\&t=1732534604319)
- First whole body CT scan after surgery (executed according to routine procedures two months after surgery) negative for cancer recurrence
- Patients highest scores of performance status, defined after multidisciplinary evaluation by Interdisciplinary Group for Tho-racic Neoplasms (GINT) using ECOG Performance Status Scale and Charlson Comorbidity Index (CCI). Subject with ECOG score 0 and CCI score from 1 to 4 is eligible.
- Informed Consent as documented by signa-ture
Exclusion
- Requirement of adjuvant treatment
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study,
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the en-tire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. (Female participants who are surgically sterilised/hysterectomised or post- meno-pausal for longer than 2 years are not considered as being of child bearing potential)
- Other clinically significant concomitant disease states (e.g., respiratory failure, COPD, interstitial lung disease, hepatic dysfunction, cardiovascular disease)
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study
- Participation in another study with investigational asset within the 30 days preceding and during the present study
- Enrolment of the investigator, his/her family members, em-ployees and other dependent persons
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07159646
Start Date
October 1 2025
End Date
September 1 2027
Last Update
September 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fondazione IRCCS Policlinico San Matteo di Pavia
Pavia, Pavia, Italy, 27100