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

Prognostic Value of Sarcopenia and Nutritional Status in Early-stage Non-small Cell Lung Cancer (Stage IA to IIIA)

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition; Sarcopenia; Non Small Cell Lung Cancer
• Intervention / Treatment: Device: Inbody 570; Device: JAMAR Dynamometer; Radiation: CT scan

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 Type: Observational
• Enrollment (Actual): 469

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huadong Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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), and the TNM staging diagnosis of early-stage NSCLC meets the stage IA-IIIA.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early-stage NSCLC with sarcopenia; Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment	Device: Inbody 570; Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up; Device: JAMAR Dynamometer; Handgrip strength measurement using a JAMAR Dynamometer (JAMAR Co., Ltd., USA) during each follow-up; Radiation: CT scan; Chest and abdominal CT scan during each follow-up
Early-stage NSCLC without sarcopenia; Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment	Device: Inbody 570; Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up; Device: JAMAR Dynamometer; Handgrip strength measurement using a JAMAR Dynamometer (JAMAR Co., Ltd., USA) during each follow-up; Radiation: CT scan; Chest and abdominal CT scan during each follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Outcome of patient death from diagnosis to any cause or the final follow-up time	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Grip Strength Test	Grip strength test at the follow-ups timepoints	6, 12, 18 and 24 months after enrollment and up to 5 years if feasible

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Ying-gang Zhu, MD, PhD, Huadong Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 27, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Nutrition Disorders; Neoplasms by Site; Neoplasms; Pathological Conditions, Anatomical; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Muscular Atrophy; Atrophy; Malnutrition; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Sarcopenia
• Other Study ID Numbers: POSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No