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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
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.
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.
Health educational material
BehavioralHealth 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 groups
324 Participants
are divided into 3 treatment groupsGroup A: Cohort A - neoadiuvant setting - interventional armExperimental treatment 1 intervention
Group B: Cohort B - adiuvant setting - interventional armExperimental treatment 1 intervention
Group C: Cohort B - adiuvant settingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment up to an average of 3 months2
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.
Time frame
From enrollment up to an average of 3 months3
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.
Time frame
From randomization to the end of follow-up at 2-year.Secondary outcomes
1
Treatment toxicities
Assessed by the local investigator and categorized according to the Common Terminology Criteria for Adverse Events (version 5.0).
Time frame
From enrollment up to 6 months.2
Overall survival
Assessed by the local investigator by checking vital status and, eventually, the date of death.
Time frame
From baseline to the end of follow-up at 2 years.3
Overall response rate
Assessed by the local investigator registering the number of patients who achieve a partial or complete response to the anticancer treatment, according to the RECIST 1.1 criteria.
Time frame
From enrollment up to 6 months.4
Disease control rate
Assessed by the local investigator registering the number of patients who achieve a stable, partial, or complete response to the anticancer treatment, according to the RECIST 1.1 criteria.
Time frame
From enrollment up to 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov