Exercise and Nutrition on Early-stage NSCLC Outcomes: the STARLighT Study

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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 dai
• Поведенческое Health 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

Первичные конечные точки

• Pathological complete response [for Cohort A] [Срок оценки: From enrollment up to an average of 3 months]
• Quality of life [for Cohort A] [Срок оценки: From enrollment up to an average of 3 months]
• Disease-free survival [for Cohort B] [Срок оценки: From randomization to the end of follow-up at 2-year.]

Вторичные конечные точки (12)

• Treatment toxicities [Срок оценки: From enrollment up to 6 months.]
• Overall survival [Срок оценки: From baseline to the end of follow-up at 2 years.]
• Overall response rate [Срок оценки: From enrollment up to 6 months.]
• Disease control rate [Срок оценки: From enrollment up to 6 months.]
• Time to treatment discontinuation [Срок оценки: From enrollment up to 6 months.]
• Immuno-inflammatory status [Срок оценки: From enrollment up to 6 months.]
• Functional capacity [Срок оценки: From enrollment up to 6 months.]
• Body mass index [Срок оценки: From enrollment up to 6 months.]
• Muscle mass [Срок оценки: From enrollment up to 6 months.]
• Sleep quality [Срок оценки: From enrollment up to 6 months.]
• Nutritional risk [Срок оценки: From enrollment up to 6 months.]
• Physical activity level [Срок оценки: From enrollment up to 6 months.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Италия · 1 центр

• Verona Hospital — Verona

Публикации

• 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 PMID 41526018

Идентификаторы

NCT: NCT07042724 · Prog. 577CET

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗