Exercise and Nutrition on Early-stage NSCLC Outcomes: the STARLighT Study

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.

Conditions

• Lung Cancer (NSCLC)

Interventions

BEHAVIORAL

Physical exercise and nutrition intervention for the neoadjuvant setting

* Physical exercise: 3 sessions/week. It will comprise high-intensity interval training consisting of 2 minutes of high-intensity intervals interspersed with 2 minutes of active recovery completed at mild intensity. The number of intervals will start with five and progress based on the patient's exercise response. Resistance training will include 3-4 exercises involving major muscle groups, performed with body weight or using elastic bands, at moderate to vigorous intensity. * Nutrition: will be directed to achieve estimated protein-calorie requirements. Total daily energy requirements will be calculated using the data obtained in the baseline assessment, while daily protein requirements will be set at 1.5 g/kg of body weight. Oral nutritional supplements, particularly a high-calorie, high-protein nutritional blend containing arginine, nucleotides \[RNA\], and omega-3 fatty acids, will be proposed.

BEHAVIORAL

Physical exercise and nutrition for the adjuvant setting

* Physical exercise: 2-3 sessions/week. Each session will be composed of: i) resistance training, including 6-8 exercises for major muscle groups performed in 2-4 sets of 8-12 repetitions; ii) aerobic component, starting at 10-20 minutes, based on the patient's baseline assessments, with monthly progressions up to 40-45 minutes at the end of the program. The insentisy will be set from moderate to vigorous. * Nutrition: will be directed to achieve estimated protein-calorie requirements. Total daily energy requirements will be calculated using the data obtained in the baseline assessment, while daily protein requirements will be set at 1.5 g/kg of body weight. Oral nutritional supplements, particularly whey protein, will be proposed.

BEHAVIORAL

Health educational material

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

Sponsors & Collaborators

• Universita di Verona

  lead OTHER

Principal Investigators

• Sara Pilotto, Ph.D., MD · Universita di Verona

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2030-04-30

Completion

2030-04-30

Countries

• Italy

Study Locations