Prognostic Value of Sarcopenia and Nutritional Status in Early-stage Non-small Cell Lung Cancer

Completed

• Conditions: Sarcopenia; Non Small Cell Lung Cancer; Malnutrition

• Registration Number: NCT05212285
• Lead Sponsor: Fudan University

Brief Summary

Growing evidence has confirmed that the prognosis of lung cancer is not only related to the stage of disease, but also to the physiological and psychological situation of the patients. Malignant tumors are often associated with weakness and cachexia, leading to less physical activities and worse moods. However, few studies that have attempted to investigate the impact of nutritional status on the prognosis of NSCLC. Existing applications of nutritional scoring systems in early-stage of NSCLC are very limited. Therefore, this study aims to observe the correlation between nutritional status and the prognosis of patients with early-stage NSCLC, to clarify the value in predicting the overall survival rate and progression-free survival rate of NSCLC patients, and to offer evidence for alleviating the social and economic burden of NSCLC.

Detailed Description

The prognosis of lung cancer is not only related to the stage of disease, but also to the physiological and psychological situation of the patients. Malignant tumors are often associated with weakness and cachexia, leading to less physical activities and worse moods. However, few studies that have attempted to investigate the impact of nutritional status on the prognosis of NSCLC. Existing applications of nutritional scoring systems in early-stage of NSCLC are very limited. Therefore, this study aims to observe the correlation between nutritional status and the prognosis of patients with early-stage NSCLC, to clarify the value in predicting the overall survival rate and progression-free survival rate of NSCLC patients, and to offer evidence for alleviating the social and economic burden of NSCLC.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-01-28
• Primary Completion: 2025-04-30
• Study Completion: 2025-04-30
• Results First Submitted: 2025-06-15
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-31
• Last Update Submitted: 2025-07-31
• Results First Posted: 2025-08-01
• Last Update Posted: 2025-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 469

Inclusion Criteria

• The patients with non-small cell lung cancer diagnosed by cytology or pathology meet the standards of clinical diagnosis and treatment guidelines for lung cancer of Chinese Medical Association (2018 Edition)
• TNM staging diagnosis of lung cancer meets the stage IA-IIIA

Exclusion Criteria

• Severe heart failure, acute progressive pulmonary inflammation, acute liver and kidney dysfunction in recent 2 weeks
• Incomplete clinical and follow-up data or disagreement or inability to conduct regular follow-up CT imaging evaluation
• A history of other malignant tumors and related tumor chemotherapy within half year, and previous history of radiotherapy
• Unable to walk, fail to complete the walking test, and the risk of fall down
• Unable to complete BIA examination due to pacemaker implantation and other reasons
• Withdraw from the study for any reasons

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	Follow-up were conducted every 2months during the first year and every 6 months for up to 5 years from enrollment. Progression-free survival was measured from the date of diagnosis until confirmed disease progression or death, whichever occurred first.	Due to the treatment frequency of lung cancer, we implemented the following follow-up schedule with actual follow-up completed for five years. Progression-free survival was measured from the date of diagnosis until the first occurrence of either: Objective tumor progression (confirmed by imaging per RECIST criteria), or death from any cause. whichever occurred first.

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	Follow-up were conducted every 2months during the first year and every 6 months for up to 5 years from enrollment. overall survival was measured from the date of diagnosis until death or the final follow-up time.	Outcome of patient death from diagnosis to any cause or the final follow-up time

Trial Locations

Locations (1)

Huadong hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China