PerSonalized nuTrition and physicAl exeRcise Intervention to Enhance earLy-staGe NSCLC ouTcomes: the STARLighT Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 324
- 试验地点
- 2
- 主要终点
- Pathological complete response [for Cohort A]
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •written informed consent.
- •willingness to use the technology/device specifically developed for patients' monitoring and support within the trial.
排除标准
- •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.
结局指标
主要结局
Pathological complete response [for Cohort A]
时间窗: 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]
时间窗: 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]
时间窗: 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.
次要结局
- Treatment toxicities(From enrollment up to 6 months.)
- Overall survival(From baseline to the end of follow-up at 2 years.)
- Overall response rate(From enrollment up to 6 months.)
- Disease control rate(From enrollment up to 6 months.)
- Time to treatment discontinuation(From enrollment up to 6 months.)
- Immuno-inflammatory status(From enrollment up to 6 months.)
- Functional capacity(From enrollment up to 6 months.)
- Body mass index(From enrollment up to 6 months.)
- Muscle mass(From enrollment up to 6 months.)
- Sleep quality(From enrollment up to 6 months.)
- Nutritional risk(From enrollment up to 6 months.)
- Physical activity level(From enrollment up to 6 months.)
- Distress level(From enrollment up to 6 months.)
- Anxiety and Depression levels(From enrollment up to 6 months.)
- Quality of life [for Cohort B](From enrollment up to 6 months.)
研究者
Sara Pilotto
MD, Ph.D
Universita di Verona