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

Not yet recruiting

• Conditions: Sarcopenia; Non Small Cell Lung Cancer; Malnutrition
• Interventions: Device: Inbody 570; Device: JAMAR Dynamometer; Radiation: CT scan

• 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

• Status Verified: 2022-01
• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-27
• Last Update Submitted: 2022-01-27
• Study First Posted: 2022-01-28
• Last Update Posted: 2022-01-28
• Study Start: 2022-01-30
• Primary Completion: 2023-10-15
• Study Completion: 2024-10-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 132

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Early-stage NSCLC with sarcopenia	Inbody 570	Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment
Early-stage NSCLC with sarcopenia	JAMAR Dynamometer	Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment
Early-stage NSCLC with sarcopenia	CT scan	Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment
Early-stage NSCLC without sarcopenia	Inbody 570	Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment
Early-stage NSCLC without sarcopenia	JAMAR Dynamometer	Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment
Early-stage NSCLC without sarcopenia	CT scan	Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	2 years after enrollment	Time from diagnosis to clinically recorded disease progression or death from any cause

Secondary Outcome Measures

Name	Time	Method
Overall survival time (OST)	6, 12, 18 and 24 months after enrollment	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