Lung Cancer (NSCLC)STARLighTNCT07042724
Exercise and Nutrition on Early-stage NSCLC Outcomes: the STARLighT Study
A study testing Physical exercise and nutrition intervention for the neoadjuvant setting, Physical exercise and nutrition for the adjuvant setting and Health educational material in people with Lung Cancer (NSCLC), run by Universita di Verona at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Physical exercise and nutrition intervention for the neoadjuvant setting, Physical exercise and nutrition for the adjuvant setting and Health educational material
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2025to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Verona Hospital
Verona, 37131
Alice Avancini, Ph.D., +39 3403624264, alice.avancini@univr.it
alice.avancini@univr.it
About this study
Official title: PerSonalized nuTrition and physicAl exeRcise Intervention to Enhance earLy-staGe NSCLC ouTcomes: the STARLighT Study
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:
Read more
- 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.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Physical exercise and nutrition intervention for the neoadjuvant setting, Physical exercise and nutrition for the adjuvant setting, Health educational material
- Keywords
- physical exercise;, nutrition;, lung cancer;
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise and nutrition intervention for the neoadjuvant settingBehavioural
- 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 settingBehavioural
- 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 materialBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical exercise and nutrition intervention for the neoadjuvant setting |
| 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. Receives: Behavioral: Physical exercise and nutrition for the adjuvant setting |
| 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 Receives: Behavioral: Health educational material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From randomization to the end of follow-up at 2-year.
Secondary outcomes (15)
Treatment toxicities
Assessed by the local investigator and categorized according to the Common Terminology Criteria for Adverse Events (version 5.0).
Measured: From enrollment up to 6 months.
Overall survival
Assessed by the local investigator by checking vital status and, eventually, the date of death.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment up to 6 months.
Body mass index
Weight and height will be combined to report body mass index in kg/m^2
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment up to 6 months.
Physical activity level
Assessed with the International Physical Activity Questionnaire.
Measured: From enrollment up to 6 months.
Distress level
Assessed with the Distress Thermometer.
Measured: 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.
Measured: 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.
Measured: From enrollment up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer (NSCLC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Pilotto, Universita di Verona
- Investigators
- Sara Pilotto, Ph.D., MD, Principal investigator, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042724
- Sponsor's protocol ID
- Prog. 577CET
- Acronym
- STARLighT
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41526018
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PerSonalized nuTrition and physicAl exeRcise Intervention to Enhance earLy-staGe NSCLC ouTcomes: the STARLighT Study
- ClinicalTrials.gov ID
- NCT07042724
- Acronym / sponsor ID
- STARLighT / Prog. 577CET
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- physical exercise;, nutrition;, lung cancer;
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort A - neoadiuvant setting - interventional arm | Experimental | Behavioral: Physical exercise and nutrition intervention for the neoadjuvant settingThis 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 | Behavioral: Physical exercise and nutrition for the adjuvant settingThis 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 | Behavioral: Health educational materialThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical 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. | Behavioural | Cohort A - neoadiuvant setting - interventional arm |
| Physical 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. | Behavioural | Cohort B - adiuvant setting - interventional arm |
| Health educational materialHealth 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 | Behavioural | Cohort B - adiuvant setting |
Primary outcome
Pathological complete response [for Cohort A]
Time frame: 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]
Time frame: 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]
Time frame: 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.
15 secondary outcomes
Treatment toxicities
Time frame: From enrollment up to 6 months.
Overall survival
Time frame: From baseline to the end of follow-up at 2 years.
Overall response rate
Time frame: From enrollment up to 6 months.
Disease control rate
Time frame: From enrollment up to 6 months.
Time to treatment discontinuation
Time frame: From enrollment up to 6 months.
Immuno-inflammatory status
Time frame: From enrollment up to 6 months.
Functional capacity
Time frame: From enrollment up to 6 months.
Body mass index
Time frame: From enrollment up to 6 months.
Muscle mass
Time frame: From enrollment up to 6 months.
Sleep quality
Time frame: From enrollment up to 6 months.
Nutritional risk
Time frame: From enrollment up to 6 months.
Physical activity level
Time frame: From enrollment up to 6 months.
Distress level
Time frame: From enrollment up to 6 months.
Anxiety and Depression levels
Time frame: From enrollment up to 6 months.
Quality of life [for Cohort B]
Time frame: From enrollment up to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Derived from this study: PubMed 41526018Avancini 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Pilotto, Ph.D., MD principal investigator
Universita di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise and nutrition intervention for the neoadjuvant setting, Physical exercise and nutrition for the adjuvant setting and Health educational material in people with Lung Cancer (NSCLC), run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alice Avancini, Ph.D. (+39 3403624264, alice.avancini@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response [for Cohort A] (time frame: From enrollment up to an average of 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07042724, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.