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

NCT07042724 | Recruiting DMC

• 1 other identifier: Prog. 577CET
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

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)

Keywords

physical exercise;; nutrition;; lung cancer;

Outcome Measures

Primary Outcomes (3)

• Pathological complete response [for Cohort A]

  Defined as a lack of any viable tumor cells after complete evaluation by the local pathologist in the resected lung cancer specimen and all sampled regional lymph nodes.

  From enrollment up to an average of 3 months

• Quality of life [for Cohort A]

  Assessed using the European Organization for Research and Treatment of Cancer Quality of Life and Core Questionnaire (EORTC QLQ C-30). The scale ranges from 0 to 100; higher values correspond to better quality of life.

  From enrollment up to an average of 3 months

• Disease-free survival [for Cohort B]

  Defined as the length of time from study inclusion to recurrence of disease, assessed with the RECIST 1.1 criteria, or death due to any cause.

  From randomization to the end of follow-up at 2-year.

Secondary Outcomes (15)

• Treatment toxicities

  From enrollment up to 6 months.

• Overall survival

  From baseline to the end of follow-up at 2 years.

• Overall response rate

  From enrollment up to 6 months.

• Disease control rate

  From enrollment up to 6 months.

• Time to treatment discontinuation

  From enrollment up to 6 months.

Study Arms (3)

Cohort A - neoadiuvant setting - interventional arm

EXPERIMENTAL

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.

Behavioral: Physical exercise and nutrition intervention for the neoadjuvant setting

Cohort B - adiuvant setting - interventional arm

EXPERIMENTAL

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.

Behavioral: Physical exercise and nutrition for the adjuvant setting

Cohort B - adiuvant setting

ACTIVE COMPARATOR

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

Behavioral: Health educational material

Interventions

Physical exercise and nutrition intervention for the neoadjuvant setting 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 A - neoadiuvant setting - interventional arm

Physical exercise and nutrition for the adjuvant setting 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 - interventional arm

Health educational material 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

Cohort B - adiuvant setting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead

Study Sites (1)

Verona Hospital

Verona, 37131, Italy

RECRUITING

Related Publications (1)

• Avancini A, Giannarelli D, Ugel S, Mafficini A, Fiorini P, Scaglione I, Adamoli G, Borsati A, Belluomini L, Eccher S, Trestini I, Tregnago D, Sposito M, Insolda J, Schena F, Scarpa A, Derosa L, Milella M, Novello S, Pilotto S. Telehealth-delivered exercise and nutrition intervention to improve outcomes in patients with early stage non-small cell lung cancer: protocol for the multicentre STARLighT phase II (neoadjuvant) and phase III (adjuvant) trial. BMJ Open. 2026 Jan 12;16(1):e108080. doi: 10.1136/bmjopen-2025-108080.

  PMID: 41526018 DERIVED

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Motor Activity

Interventions

Exercise; Diet Therapy; Nutritional Status

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Nutrition Therapy; Therapeutics; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Officials

• Sara Pilotto, Ph.D., MD

  Universita di Verona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice Avancini, Ph.D.

CONTACT

+39 3403624264; alice.avancini@univr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D

Model Details: A master clinical protocol will be set up to evaluate the exercise and nutritional interventions in different cohorts of patients diagnosed with non-oncogene addicted with early-stage NSCLC. Cohort A, assessing exercise and nutrition in the neoadjuvant lung cancer setting, will exploit a single-arm design. Cohort B, assessing exercise and nutrition in the adjuvant lung cancer setting, will exploit a randomized controlled design.

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 29, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)