Malnutrition, Non Small Cell Lung Cancer, Sarcopenia
Conditions
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.
Interventions
DEVICEInbody 570
Bioelectrical Impedance Analysis with Inbody 570 (Inbody Co., Seoul, Korea) during each follow-up
DEVICEJAMAR Dynamometer
Handgrip strength measurement using a JAMAR Dynamometer (JAMAR Co., Ltd., USA) during each follow-up
RADIATIONCT scan
Chest and abdominal CT scan during each follow-up
Sponsors
Fudan University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Grip Strength Test | 6, 12, 18 and 24 months after enrollment and up to 5 years if feasible | Grip strength test at the follow-ups timepoints |
Countries
China
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 229 |
| 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 | 174 |
| Total | 403 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 12 | 8 |
| Overall Study | Lost to Follow-up | 13 | 1 |
| Overall Study | miss data | 21 | 2 |
| Overall Study | Withdrawal by Subject | 8 | 1 |
Baseline characteristics
| Characteristic | Total | Early-stage NSCLC Without Sarcopenia | Early-stage NSCLC With Sarcopenia |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 333 Participants | 179 Participants | 154 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 50 Participants | 20 Participants |
| Age, Continuous | 72.2 years STANDARD_DEVIATION 8.2 | 71 years STANDARD_DEVIATION 8.2 | 74.3 years STANDARD_DEVIATION 7.7 |
| cancer stage I-II | 84 Participants | 56 Participants | 28 Participants |
| cancer stage III-IV | 319 Participants | 173 Participants | 146 Participants |
| handgrip sthength | 27.4 kg STANDARD_DEVIATION 8.4 | 30.8 kg STANDARD_DEVIATION 7.8 | 23.4 kg STANDARD_DEVIATION 7.1 |
| Historical type adenocarcinoma | 262 Participants | 149 Participants | 113 Participants |
| Historical type others | 7 Participants | 6 Participants | 1 Participants |
| Historical type small cell lung cancer | 34 Participants | 23 Participants | 11 Participants |
| Historical type squamous cell carcinoma | 100 Participants | 51 Participants | 49 Participants |
| nrs2002 score | 3.1 score on a scale STANDARD_DEVIATION 1.5 | 2.6 score on a scale STANDARD_DEVIATION 1.2 | 3.7 score on a scale STANDARD_DEVIATION 1.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 403 Participants | 229 Participants | 174 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 114 Participants | 73 Participants | 41 Participants |
| Sex: Female, Male Male | 289 Participants | 156 Participants | 133 Participants |
| Skeletal muscle mass index | 6.8 kg/m^2 STANDARD_DEVIATION 0.9 | 7.2 kg/m^2 STANDARD_DEVIATION 0.9 | 6.3 kg/m^2 STANDARD_DEVIATION 0.7 |
| Smoking status Ex-smoker | 134 Participants | 74 Participants | 60 Participants |
| Smoking status Non-smoker | 226 Participants | 123 Participants | 103 Participants |
| Smoking status Smoker | 43 Participants | 32 Participants | 11 Participants |
| walking speed | 0.9 m/s STANDARD_DEVIATION 0.3 | 0.7 m/s STANDARD_DEVIATION 0.3 | 1.0 m/s STANDARD_DEVIATION 0.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 123 / 174 | 76 / 229 |
| other Total, other adverse events | 0 / 174 | 0 / 229 |
| serious Total, serious adverse events | 0 / 174 | 0 / 229 |
Outcome results
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.
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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Early-stage NSCLC With Sarcopenia | Progression Free Survival (PFS) | 350 days | Standard Error 46.4 |
| Early-stage NSCLC Without Sarcopenia | Progression Free Survival (PFS) | 773 days | Standard Error 46.1 |
Secondary
Overall Survival (OS)
Outcome of patient death from diagnosis to any cause or the final follow-up time
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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Early-stage NSCLC With Sarcopenia | Overall Survival (OS) | 1319 days | Standard Error 172.5 |
| Early-stage NSCLC Without Sarcopenia | Overall Survival (OS) | 402 days | Standard Error 49.9 |
Other Pre-specified
Grip Strength Test
Grip strength test at the follow-ups timepoints
Time frame: 6, 12, 18 and 24 months after enrollment and up to 5 years if feasible