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

NCT ID: NCT07042724

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2030-04-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical exercise and nutrition intervention for the neoadjuvant setting

Intervention Type: BEHAVIORAL

• 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.

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.

Group Type: EXPERIMENTAL

Physical exercise and nutrition for the adjuvant setting

Intervention Type: BEHAVIORAL

• 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.

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

Group Type: ACTIVE_COMPARATOR

Health educational material

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• evidence in the medical record of absolute contraindications to exercise, nutritional, or psychological intervention [i.e., heart insufficiency; uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction, bone marrow insufficiency); reduced standing or walking ability; myocardial infarction].
• indications for or ongoing artificial nutrition support (totally compromised spontaneous food intake).
• incapacity, or unavailability to consume oral nutritional supplements.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universita di Verona

OTHER

Sponsor Role: lead

Responsible Party

Sara Pilotto

MD, Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Pilotto, Ph.D., MD

Role: PRINCIPAL_INVESTIGATOR

Universita di Verona

Locations

Verona Hospital

Verona, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alice Avancini, Ph.D.

Role: CONTACT

alice.avancini@univr.it

+39 3403624264

Facility Contacts

Alice Avancini, Ph.D.

Role: primary

alice.avancini@univr.it

+39 3403624264

Role: backup

alice.avancini@univr.it

Other Identifiers

Prog. 577CET

Identifier Type: -

Identifier Source: org_study_id