PerSonalized nuTrition and physicAl exeRcise Intervention to Enhance earLy-staGe NSCLC ouTcomes: the STARLighT Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The general goal of the STARLighT study is to test whether a structured physical exercise and nutritional intervention significantly impacts clinical outcomes in patients with early-stage lung cancer. The main questions it aims to answer are: * Can structured physical exercise and nutrition intervention positively modify the pathological complete response in patients with early-stage lung cancer undergoing neoadjuvant treatments? * Can structured physical exercise and nutrition intervention positively influence disease-free survival in patients with early-stage lung cancer undergoing adjuvant treatments compared to usual care? This study will recruit two cohorts of patients. Cohort A will accrue patients who are candidates for neoadjuvant treatment and offer the opportunity to participate in a structured physical exercise and nutritional program, lasting the entire period of anticancer treatment. Cohort B will accrue patients who are candidates for adjuvant treatments. Patients will be randomized to receive 6 months of structured physical exercise and nutritional intervention or standard of care.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• age ≥ 18 years.

• confirmed diagnosis of resectable or resected non-oncogene addicted NSCLC (EGFR, ALK wild-type).

• stage IB to IIIB.

• candidate or undergoing systemic treatment.

• ECOG performance status 0-1.

• written informed consent.

• willingness to use the technology/device specifically developed for patients' monitoring and support within the trial.

Locations
Other Locations
Italy
Verona Hospital
RECRUITING
Verona
Contact Information
Primary
Alice Avancini, Ph.D.
alice.avancini@univr.it
+39 3403624264
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2030-04-30
Participants
Target number of participants: 324
Treatments
Experimental: Cohort A - neoadiuvant setting - interventional arm
This arm will include patients undergoing neoadjuvant chemoimmunotherapy. The administered intervention will consist of a combination of exercise and nutrition support for the entire neoadjuvant treatment period.
Experimental: Cohort B - adiuvant setting - interventional arm
This arm will include patients undergoing adjuvant treatment as per standard of care. The administered intervention will consist of a combination of exercise and nutrition support lasting 6 months.
Active_comparator: Cohort B - adiuvant setting
This arm will include patients undergoing adjuvant treatment as per standard of care. The administered intervention, lasting 6 months, will consist of health educational materials, including the benefits of exercise and nutrition during cancer care, the current recommendations, and information on how to pursue them, as well as strategies to achieve and maintain a healthy psychological status
Related Therapeutic Areas
Sponsors
Leads: Universita di Verona

This content was sourced from clinicaltrials.gov