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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A - neoadiuvant setting - interventional arm | Experimental | 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. |
|
| Cohort B - adiuvant setting - interventional arm | Experimental | 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. |
|
| Cohort B - adiuvant setting | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical exercise and nutrition intervention for the neoadjuvant setting | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | From randomization to the end of follow-up at 2-year. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment toxicities | Assessed by the local investigator and categorized according to the Common Terminology Criteria for Adverse Events (version 5.0). | From enrollment up to 6 months. |
| Overall survival |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alice Avancini, Ph.D. | Contact | +39 3403624264 | alice.avancini@univr.it |
| Name | Affiliation | Role |
|---|---|---|
| Sara Pilotto, Ph.D., MD | Universita di Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Verona Hospital | Recruiting | Verona | 37131 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41526018 | Derived | Avancini A, Giannarelli D, Ugel S, Mafficini A, Fiorini P, Scaglione I, Adamoli G, Borsati A, Belluomini L, Eccher S, Trestini I, Tregnago D, Sposito M, Insolda J, Schena F, Scarpa A, Derosa L, Milella M, Novello S, Pilotto S. Telehealth-delivered exercise and nutrition intervention to improve outcomes in patients with early stage non-small cell lung cancer: protocol for the multicentre STARLighT phase II (neoadjuvant) and phase III (adjuvant) trial. BMJ Open. 2026 Jan 12;16(1):e108080. doi: 10.1136/bmjopen-2025-108080. |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D004035 | Diet Therapy |
| D009752 | Nutritional Status |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
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|
| Physical exercise and nutrition for the adjuvant setting | Behavioral |
|
|
| Health educational material | Behavioral | 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 |
|
Assessed by the local investigator by checking vital status and, eventually, the date of death.
| 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. | 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. | 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. | 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. | 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. | From enrollment up to 6 months. |
| Body mass index | Weight and height will be combined to report body mass index in kg/m^2 | 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. | 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. | 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. | From enrollment up to 6 months. |
| Physical activity level | Assessed with the International Physical Activity Questionnaire. | From enrollment up to 6 months. |
| Distress level | Assessed with the Distress Thermometer. | 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. | 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. | From enrollment up to 6 months. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D001519 | Behavior |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006304 | Health Status |
| D003710 | Demography |
| D011154 | Population Characteristics |