Lung Cancer (NSCLC)
Conditions
Keywords
physical exercise;, nutrition;, lung cancer;
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.
Interventions
BEHAVIORALPhysical exercise and nutrition intervention for the neoadjuvant setting
* 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.
BEHAVIORALPhysical exercise and nutrition for the adjuvant setting
* 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.
BEHAVIORALHealth educational material
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
Sponsors
Universita di Verona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response [for Cohort A] | From enrollment up to an average of 3 months | 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. |
| Quality of life [for Cohort A] | From enrollment up to an average of 3 months | 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. |
| Disease-free survival [for Cohort B] | From randomization to the end of follow-up at 2-year. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate | From enrollment up to 6 months. | 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 to treatment discontinuation | From enrollment up to 6 months. | Assessed by the local investigator by registering the date and the cause of the treatment discontinuation. |
| Immuno-inflammatory status | From enrollment up to 6 months. | Evaluated through the collection of peripheral blood samples. Circulating immuno-inflammatory parameters will be tested using multiplex ELISA. |
| Functional capacity | From enrollment up to 6 months. | 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. |
| Body mass index | From enrollment up to 6 months. | Weight and height will be combined to report body mass index in kg/m\^2 |
| Muscle mass | From enrollment up to 6 months. | 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. |
| Treatment toxicities | From enrollment up to 6 months. | Assessed by the local investigator and categorized according to the Common Terminology Criteria for Adverse Events (version 5.0). |
| Nutritional risk | From enrollment up to 6 months. | 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. |
| Physical activity level | From enrollment up to 6 months. | Assessed with the International Physical Activity Questionnaire. |
| Distress level | From enrollment up to 6 months. | Assessed with the Distress Thermometer. |
| Anxiety and Depression levels | From enrollment up to 6 months. | 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. |
| Quality of life [for Cohort B] | From enrollment up to 6 months. | 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. |
| Sleep quality | From enrollment up to 6 months. | Assessed with the Pittsburgh Sleep Quality questionnaire. The scale ranges from 0 to 21. Lower values indicate better sleep quality. |
| Overall survival | From baseline to the end of follow-up at 2 years. | Assessed by the local investigator by checking vital status and, eventually, the date of death. |
| Overall response rate | From enrollment up to 6 months. | 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. |
Countries
Italy
Contacts
Primary ContactAlice Avancini, Ph.D.
Outcome results
None listed