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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
324
* 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: 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 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
Verona Hospital
Verona, Italy
RECRUITINGPathological 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 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.
Time frame: 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.
Time frame: From randomization to the end of follow-up at 2-year.
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.
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.
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.
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.
Time to treatment discontinuation
Assessed by the local investigator by registering the date and the cause of the treatment discontinuation.
Time frame: From enrollment up to 6 months.
Immuno-inflammatory status
Evaluated through the collection of peripheral blood samples. Circulating immuno-inflammatory parameters will be tested using multiplex ELISA.
Time frame: From enrollment up to 6 months.
Functional capacity
Assessed with the validated Fitmax Questionnaire, a self-reported questionnaire that estimates cardiorespiratory fitness by quantifying the capacity of walking, cycling, and stair climbing. The scale scores from 0 to 100; higher values correspond to a better functional capacity.
Time frame: From enrollment up to 6 months.
Body mass index
Weight and height will be combined to report body mass index in kg/m\^2
Time frame: From enrollment up to 6 months.
Muscle mass
Estimated using a single-slice transverse CT scan of the third lumbar vertebra, acquired for routine clinical care, using the SliceOmatic version 5.0 (TomoVision) software. This methodology is largely utilized in the oncological setting because it has the advantage of providing high accuracy and reproducible results. The following measure will be quantified: skeletal muscle area (SMA) in cm\^2.
Time frame: From enrollment up to 6 months.
Sleep quality
Assessed with the Pittsburgh Sleep Quality questionnaire. The scale ranges from 0 to 21. Lower values indicate better sleep quality.
Time frame: From enrollment up to 6 months.
Nutritional risk
Assessed with the Nutritional Risk Screening 2002 (NRS-2002). The scale scores from 0 to 7; higher values correspond to a higher risk of malnutrition.
Time frame: From enrollment up to 6 months.
Physical activity level
Assessed with the International Physical Activity Questionnaire.
Time frame: From enrollment up to 6 months.
Distress level
Assessed with the Distress Thermometer.
Time frame: From enrollment up to 6 months.
Anxiety and Depression levels
Assessed with the Hospital Anxiety and Depression Scale. The scale scores from 0 to 42. Higher values correspond to a higher level of anxiety and depression.
Time frame: From enrollment up to 6 months.
Quality of life [for Cohort B]
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 6 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.