Prognostic Value of Sarcopenia and Nutritional Status in Early-stage Non-small Cell Lung Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Early-stage NSCLC with sarcopenia Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment |
Device: Inbody 570
Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up
Device: 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
|
| Early-stage NSCLC without sarcopenia Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment |
Device: Inbody 570
Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up
Device: 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
|
Outcome Measures
Primary Outcome Measures
- Progression free survival (PFS) [2 years after enrollment]
Time from diagnosis to clinically recorded disease progression or death from any cause
Secondary Outcome Measures
- Overall survival time (OST) [6, 12, 18 and 24 months after enrollment]
Outcome of patient death from diagnosis to any cause or the final follow-up time
Other Outcome Measures
- Nutritional score (MNA) [6, 12, 18 and 24 months after enrollment]
Nutritional score (MNA)
- Skeletal muscle mass [6, 12, 18 and 24 months after enrollment]
Skeletal muscle mass
- Grip strength test [6, 12, 18 and 24 months after enrollment]
Grip strength test
- 6-meter distance pace measurement [6, 12, 18 and 24 months after enrollment]
Walking test
Eligibility Criteria
Criteria
Inclusion Criteria:
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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)
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TNM staging diagnosis of lung cancer meets the stage IA-IIIA
Exclusion Criteria:
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Severe heart failure, acute progressive pulmonary inflammation, acute liver and kidney dysfunction in recent 2 weeks
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Incomplete clinical and follow-up data or disagreement or inability to conduct regular follow-up CT imaging evaluation
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A history of other malignant tumors and related tumor chemotherapy within half year, and previous history of radiotherapy
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Unable to walk, fail to complete the walking test, and the risk of fall down
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Unable to complete BIA examination due to pacemaker implantation and other reasons
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Withdraw from the study for any reasons
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huadong hospital, Fudan University | Shanghai | Shanghai | China | 200040 |
Sponsors and Collaborators
- Fudan University
Investigators
- Principal Investigator: Ying-gang Zhu, MD, PhD, Huadong Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- POSE