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

University of Verona

Status: Enrolling

Conditions: Lung Cancer (NSCLC)

Treatments: Behavioral: Physical exercise and nutrition for the adjuvant setting; Behavioral: Health educational material; Behavioral: Physical exercise and nutrition intervention for the neoadjuvant setting

Study type: Interventional

Funder types: Other

Identifiers

NCT07042724

Prog. 577CET

Details and patient eligibility

About

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.

Enrollment: 324 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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324 participants in 3 patient groups

Cohort A - neoadiuvant setting - interventional arm

Experimental group

Description:

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.

Treatment:

Behavioral: Physical exercise and nutrition intervention for the neoadjuvant setting

Cohort B - adiuvant setting - interventional arm

Experimental group

Description:

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.

Treatment:

Behavioral: Physical exercise and nutrition for the adjuvant setting

Cohort B - adiuvant setting

Active Comparator group

Description:

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

Treatment:

Behavioral: Health educational material