Clinical trial NCT05212285: Prognostic Value of Sarcopenia and Nutritional Status in Early-stage Non-small Cell Lung Cancer
Official title: Prognostic Value of Sarcopenia and Nutritional Status in Early-stage Non-small Cell Lung Cancer (Stage IA to IIIA)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcopenia
Non Small Cell Lung Cancer
Malnutrition
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 2 years after enrollment
Secondary outcomes:
measure: Overall survival time (OST)
timeFrame: 6, 12, 18 and 24 months after enrollment
Other outcomes:
measure: Nutritional score (MNA)
timeFrame: 6, 12, 18 and 24 months after enrollment
measure: Skeletal muscle mass
timeFrame: 6, 12, 18 and 24 months after enrollment
measure: Grip strength test
timeFrame: 6, 12, 18 and 24 months after enrollment
measure: 6-meter distance pace measurement
timeFrame: 6, 12, 18 and 24 months after enrollment
Locations:
city: Shanghai
country: China
facility: Huadong hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Huadong Hospital
name: Ying-gang Zhu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: