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NCT Number: NCT05212285

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

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.

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Key information

Conditions

Sarcopenia Atrophy Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Malnutrition Muscular Atrophy Neoplasms Neoplasms by Site Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Non Small Cell Lung Cancer Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Thoracic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Huadong hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inbody 570

Device

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

JAMAR Dynamometer

Device

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

CT Scan

Radiation

Chest and abdominal CT scan during each follow-up

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: 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 outcomes

  1. Overall Survival (OS)

    Time frame: 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

Other outcomes

  1. Grip Strength Test

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

    Grip strength test at the follow-ups timepoints

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2022
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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