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

NCT05212285 | Completed Results

• 1 other identifier: POSE
• Study Type: observational
• Target: 469
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia; Non Small Cell Lung Cancer; Malnutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Other Outcomes (1)

• Grip Strength Test

  6, 12, 18 and 24 months after enrollment and up to 5 years if feasible

Study Arms (2)

Early-stage NSCLC with sarcopenia

Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment

Device: Inbody 570; Device: JAMAR Dynamometer; Radiation: CT scan

Early-stage NSCLC without sarcopenia

Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment

Device: Inbody 570; Device: JAMAR Dynamometer; Radiation: CT scan

Interventions

Inbody 570 DEVICE

Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up

Early-stage NSCLC with sarcopenia; Early-stage NSCLC without sarcopenia

JAMAR Dynamometer DEVICE

Handgrip strength measurement using a JAMAR Dynamometer (JAMAR Co., Ltd., USA) during each follow-up

Early-stage NSCLC with sarcopenia; Early-stage NSCLC without sarcopenia

CT scan RADIATION

Chest and abdominal CT scan during each follow-up

Early-stage NSCLC with sarcopenia; Early-stage NSCLC without sarcopenia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Sarcopenia; Carcinoma, Non-Small-Cell Lung; Malnutrition

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Dr.Yinggang Zhu,Dr Ting Zhao
• Organization: Huadong hospital,Shanghai ,China

robinzyg-zhu@vip.sina.com;vivianzaza@163.com

1374321007

Study Officials

• Ying-gang Zhu, MD, PhD

  Huadong Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 28, 2022
• Study Start: January 1, 2020
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 1, 2025
• Results First Posted: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)