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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early-stage NSCLC with sarcopenia | Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment |
| |
| Early-stage NSCLC without sarcopenia | Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inbody 570 | Device | Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Outcome of patient death from diagnosis to any cause or the final follow-up time | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Grip Strength Test | Grip strength test at the follow-ups timepoints | 6, 12, 18 and 24 months after enrollment and up to 5 years if feasible |
Inclusion Criteria:
Exclusion 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), and the TNM staging diagnosis of early-stage NSCLC meets the stage IA-IIIA.
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| Name | Affiliation | Role |
|---|---|---|
| Ying-gang Zhu, MD, PhD | Huadong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huadong hospital, Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
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The patients were diagnosed with non-small cell lung cancer (NSCLC) by cytological or pathological examination and met the relevant criteria of the Chinese Medical Association Guidelines for Clinical Diagnosis and Treatment of Lung Cancer (2018 Edition). The TNM staging of lung cancer was confirmed as stage IA-IIIA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Early-stage NSCLC With Sarcopenia | Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment 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 CT scan: Chest and abdominal CT scan during each follow-up |
| FG001 | Early-stage NSCLC Without Sarcopenia | Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment 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 CT scan: Chest and abdominal CT scan during each follow-up |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
china,Huadong Hospital
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| ID | Title | Description |
|---|---|---|
| BG000 | Early-stage NSCLC Without Sarcopenia | Patients diagnosed with NSCLC meeting Stage IA-IIIA but without sarcopenia by the enrollment 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 CT scan: Chest and abdominal CT scan during each follow-up |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Progression Free Survival (PFS) | 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. | Posted | Median | Standard Error | days | 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 tumor, we implemented the following follow-up schedule and documented adverse events at each follow-up visit. Follow-up assessments were performed every 2 months during the first year after enrollment (baseline), then every 6 months until 5 years . Adverse events were monitored at each follow-up visit .
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lung Cancer With Sarcopenia | The patients were diagnosed with non-small cell lung cancer (NSCLC) by cytological or pathological examination and met the relevant criteria of the Chinese Medical Association Guidelines for Clinical Diagnosis and Treatment of Lung Cancer (2018 Edition). meanwhile diagnosed with sarcopenia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Yinggang Zhu,Dr Ting Zhao | Huadong hospital,Shanghai ,China | 1374321007 | +86 | robinzyg-zhu@vip.sina.com;vivianzaza@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2021 | Jul 13, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 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 |
|
| Lost to Follow-up |
|
| miss data |
|
| BG001 | Early-stage NSCLC With Sarcopenia | Patients diagnosed with NSCLC meeting Stage IA-IIIA as well as sarcopenia by the enrollment 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 CT scan: Chest and abdominal CT scan during each follow-up |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| walking speed | Mean | Standard Deviation | m/s |
|
| handgrip sthength | Mean | Standard Deviation | kg |
|
| Skeletal muscle mass index | Mean | Standard Deviation | kg/m^2 |
|
| cancer stage | tumor staging according to AJCC 8th edition TNM lassification:T Category T1-T4:Assesses tumor size, location and local invasionN Category (N0-N3):Evaluates regional lymph node involvementRanges from no spread (N0) to contralateral spread (N3)M Category (M1a-c):Identifies distant metastases Classifies by metastasis type/location；Stage Groupings:Stage I-II includingT1-T2 tumors (≤5cm, no critical structure invasion)N0 lymph nodesM0 (no metastases) Stage III :T3-T4 tumors (>5cm or local invasion)N1-N3 lymph node involvementM0Stage IV (Metastatic):Any T/N classification M1 (distant metastases) | Count of Participants | Participants |
|
| Smoking status | Count of Participants | Participants |
|
| nrs2002 score | The NRS 2002 is a validated screening tool used to identify hospitalized patients at risk of malnutrition or nutritional deterioration. It assesses nutritional status and disease severity, with higher scores indicating worse prognosis.The total score ranges from 0 to 7,0: No nutritional risk → Routine clinical care.1-3: Mild to moderate risk → Consider nutritional support.≥4: High risk → Immediate nutritional intervention required. | Mean | Standard Deviation | score on a scale |
|
| Historical type | Lung cancer is broadly categorized into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC).NSCLC includes:Adenocarcinoma: Arises from bronchial glands, with subtypes such as lepidic, acinar, and micropapillary; often harbors EGFR/ALK mutations.Squamous cell carcinoma Strongly associated with smoking, typically central, and rarely targetable.Large cell carcinoma: Undifferentiated and highly aggressive. | Count of Participants | Participants |
|
| Early-stage NSCLC Without Sarcopenia |
Patients who exhibiting disease progression without sarcopenia |
|
|
| Secondary | Overall Survival (OS) | Outcome of patient death from diagnosis to any cause or the final follow-up time | Posted | Median | Standard Error | days | 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. |
|
|
|
| Other Pre-specified | Grip Strength Test | Grip strength test at the follow-ups timepoints | Not Posted | Jun 2025 | 6, 12, 18 and 24 months after enrollment and up to 5 years if feasible | Participants |
| 123 |
| 174 |
| 0 |
| 174 |
| 0 |
| 174 |
| EG001 | Lung Cancer Without Sarcopenia | The patients were diagnosed with non-small cell lung cancer (NSCLC) by cytological or pathological examination and met the relevant criteria of the Chinese Medical Association Guidelines for Clinical Diagnosis and Treatment of Lung Cancer (2018 Edition). meanwhile diagnosed without sarcopenia | 76 | 229 | 0 | 229 | 0 | 229 |
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| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |