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

NCT ID: NCT05212285

Last Updated: 2025-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

469 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2025-04-30

Brief Summary

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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

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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

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Sarcopenia Non Small Cell Lung Cancer Malnutrition

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Early-stage NSCLC with sarcopenia

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

Inbody 570

Intervention Type DEVICE

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

JAMAR Dynamometer

Intervention Type DEVICE

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

CT scan

Intervention Type RADIATION

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

Inbody 570

Intervention Type DEVICE

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

JAMAR Dynamometer

Intervention Type DEVICE

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

CT scan

Intervention Type RADIATION

Chest and abdominal CT scan during each follow-up

Interventions

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Inbody 570

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

Intervention Type DEVICE

JAMAR Dynamometer

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

Intervention Type DEVICE

CT scan

Chest and abdominal CT scan during each follow-up

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Zhijun Bao

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ying-gang Zhu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Huadong Hospital

Locations

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Huadong hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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POSE

Identifier Type: -

Identifier Source: org_study_id

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