Exercise and Nutrition on Early-stage NSCLC Outcomes: the STARLighT Study
ConditionLung Cancer (NSCLC)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversita di Verona
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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
Treatments tested in this trial
- Physical exercise and nutrition intervention for the neoadjuvant setting
- Physical exercise and nutrition for the adjuvant setting
- Health educational material
Treatment groups
324 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov