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NCT Number: NCT07042724

Exercise and Nutrition on 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:

* 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.

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Key information

Conditions

Lung Cancer (NSCLC) Behavior Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Motor Activity Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Treatment toxicities

    Time frame: 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).

  2. Overall survival

    Time frame: 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.

  3. Overall response rate

    Time frame: 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.

  4. Disease control rate

    Time frame: 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.

  5. Time to treatment discontinuation

    Time frame: From enrollment up to 6 months.

    Assessed by the local investigator by registering the date and the cause of the treatment discontinuation.

  6. Immuno-inflammatory status

    Time frame: From enrollment up to 6 months.

    Evaluated through the collection of peripheral blood samples. Circulating immuno-inflammatory parameters will be tested using multiplex ELISA.

  7. Functional capacity

    Time frame: 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.

  8. Body mass index

    Time frame: From enrollment up to 6 months.

    Weight and height will be combined to report body mass index in kg/m^2

  9. Muscle mass

    Time frame: 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.

  10. Sleep quality

    Time frame: 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.

  11. Nutritional risk

    Time frame: 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.

  12. Physical activity level

    Time frame: From enrollment up to 6 months.

    Assessed with the International Physical Activity Questionnaire.

  13. Distress level

    Time frame: From enrollment up to 6 months.

    Assessed with the Distress Thermometer.

  14. Anxiety and Depression levels

    Time frame: 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.

  15. Quality of life [for Cohort B]

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Avancini, Ph.D.

CONTACT

[email protected]

+39 3403624264

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

PerSonalized nuTrition and physicAl exeRcise Intervention to Enhance earLy-staGe NSCLC ouTcomes: the STARLighT Study

Acronym: STARLighT

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Jun 29, 2025
Registry last updated
Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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