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

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05212285
• Other study ID #: POSE
• Status: Not yet recruiting
• Start date: January 30, 2022
• Est. completion date: October 15, 2024

Study information

• Verified date: January 2022
• Source: Fudan University
• Contact: Ting Zhao, MD
• Phone: +86-21-62483180
• Email: 65375201[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 132
• Est. completion date: October 15, 2024
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Malnutrition
• Non Small Cell Lung Cancer
• Sarcopenia

Intervention

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

Locations

Country	Name	City	State
China	Huadong hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Nutritional score (MNA)	Nutritional score (MNA)	6, 12, 18 and 24 months after enrollment
Other	Skeletal muscle mass	Skeletal muscle mass	6, 12, 18 and 24 months after enrollment
Other	Grip strength test	Grip strength test	6, 12, 18 and 24 months after enrollment
Other	6-meter distance pace measurement	Walking test	6, 12, 18 and 24 months after enrollment
Primary	Progression free survival (PFS)	Time from diagnosis to clinically recorded disease progression or death from any cause	2 years after enrollment
Secondary	Overall survival time (OST)	Outcome of patient death from diagnosis to any cause or the final follow-up time	6, 12, 18 and 24 months after enrollment