Extension Protocol for the Investigation on Nutrition Status and Clinical Outcome of Patients with Common Cancers in China(INSCOC)Study:2021 update

Background Malnutrition is common in patients with cancer,and this adversely affects the survival and quality of life of patients.Chinese Society for Nutritional Oncology issued a multi-center,large-scale,long-term follow-up prospective study,the Investigation on Nutrition Status and Clinical Outcome of Patients with Common Cancers in China(INSCOC study)since 2013.This is an extension to the previous 2013-2020 study protocol.This study still sought to:①address the prognostic impact of nutritional factors and quality of life on cancer patient survival;②describe the overall and cancer-specific incidence and/or distribution of malnutrition and different measurements of patient quality of life.Methods and study design This is an observational,multi-centered,hospital-based prospective cohort study.Data collection will be performed at baseline(within 48 hours after patient admission),during the hospital stay and 30 days after hospital admission.Follow-up will be conducted for 1-20 years after enrollment.The primary outcome will be the all-cause mortality/overall survival,and secondary outcomes will be the length of hospital stay and costs of hospitalization.Study factors will include demographic characteristics,tumor characteristics,information about chronic diseases,hematological measurements(e.g.,red blood cell count,total lymphocyte counts,hemoglobin,albumin,prealbumin,creatinine,C-reactive protein,IL-6),anthropometric measurements(e.g.,height,weight,arm circumference,arm muscle circumference,triceps skinfold thickness,and waist circumference),body composition parameters,PG-SGA scores,quality of life(as indicated by the QLQ-C30 questionnaire),muscle mass(as indicated by the calf circumference),muscle strength(as indicated by the handgrip strength),muscle function(as indicated by the six-meter walking speed test)and physical status assessments(as indicated by the Karnofsky Performance Status scores).This clinical study protocol was approved by local Ethics Committees of all the participating hospitals.Written informed consent is required for each subject included.Discussion This multi-center,large-scale,long-term follow up prospective study will help improve the diagnosis of malnutrition in cancer patients and identify the risk factors associated with adverse clinical outcomes.The anticipated results of this study will highlight the need for a truly scientific appraisal of nutrition therapy in Chinese oncology populations,and finally help treat the potentially reversible elements of malnutrition in cancer patients to improve their clinical outcomes in the future.

Malnutrition and Quality of Life in Chinese Cancer Patients: a Clinical Study of 23,994 Subjects

Background Malnutrition is common in patients with cancer,and can negatively impact their quality of life(QoL)and even survival.However,there is currently no large data available on the prevalence of malnutrition in Chinese cancer patients.This study evaluated the prevalence of malnutrition and the QoL of Chinese patients with locoregional,recurrent or metastatic cancer.Methods We conducted a nationwide observational,multi-center,hospital-based cross-sectional study within the Chinese Society of Nutritional Oncology(CSNO)Network.All of the patients were diagnosed with one of the following 18 different types of malignant tumors:lung cancer,gastric cancer,liver cancer,colorectal cancer,breast cancer,esophageal cancer,cervical cancer,endometrial cancer,nasopharyngeal carcinoma,malignant lymphoma,leukemia,pancreatic cancer,ovarian cancer,prostate cancer,bladder cancer,brain cancer,biliary tract malignant tumors or gastrointestinal stromal tumors.These patients were enrolled from 72 hospitals located in different regions of China.The patients’nutritional status was evaluated based on the body mass index(BMI),loss of bodyweight,laboratory measurements and patient generated-subjective global assessment(PG-SGA)scores.The cancer patients’physical status and QoL were assessed by the Karnofsky Performance Status(KPS)questionnaire and the European Organization for Research and Treatment of Cancer(EORTC)QLQ-C30 questionnaire,respectively.Results From December 2013 to April 2016,23,994 patients hospitalized for cancer treatment(such as surgery,chemotherapy or radiotherapy)were enrolled in the study.The patients included 12,494(52.9%)males and 11,124(47.1%)females.The mean age was 55.8±13.7 years.The proportions of patients in cancer stagesⅠ,Ⅱ,Ⅲ,Ⅳand uncertain were 11.5%,20.3%,27.5%,30.2%and 10.5%,respectively.Among the 23,994 inpatients,the proportions of patients who were underweight(BMI<18.5 kg/m2),normal(18.5 kg/m2<BMI<24 kg/m2),overweight(24 kg/m2≤BMI<28 kg/m2)and obese(BMI≥28 kg/m2)were 9.3%,59.9%,26.1%and 4.7%,respectively.A total of 18.3%(4,101/22,424)of patients had lost 5%or more of their bodyweight within the past month and 19.6%(2,463/12,538)of patients had lost 10%or more of their bodyweight within the past 6 months.According to the PG-SGA scores,26.6%of the patients were severely malnourished(score≥9),31.3%were moderately malnourished(scores 4~8).A total of 22.2%of patients had a serum albumin level lower than 35g/L.Only 8.6%(2056/23,991)of the patients had severe KPS scores(≤60).The patients with these severe KPS scores were most frequently among those with cancers of the brain(19.7%),prostate(18.0%),pancreas(15.5%)and bladder(15.0%).Based on the QLQ-C30 score,11.6%of patients had a poor QoL.The PG-SGA score and global QoL were correlated(r=-0.593,P<0.001).Conclusion The prevalence of malnutrition in patients with cancer is relatively high,and is related to a poorer QoL.The present findings should be kept in mind when assessing cancer patients,because addressing the patient’s problems in nutritional status would be expected to improve both the clinical outcomes and QoL in cancer patients with malnutrition.

AIWW:a new nutrition-screening tool for the oncologic population

Malnutrition is a common comorbidity among patients with cancer.However,no nutrition-screening tool has been recognized in this population.A quick and easy screening tool for nutrition with high sensitivity and easy-to-use is needed.Based on the previous 25 nutrition-screening tools,the Delphi method was made by the members of the Chinese Society of Nutritional Oncology to choose the most useful item from each category.According to these results,we built a nutrition-screening tool named age,intake,weight,and walking(AIWW).Malnutrition was defined based on the scored patient-generated subjective global assessment(PG-SGA).Concurrent validity was evaluated using the Kendall tau coefficient and kappa consistency between the malnutrition risks of AIWW,nutritional risk screening 2002(NRS-2002),and malnutrition screening tool(MST).Clinical benefit was calculated by the decision curve analysis(DCA),integrated discrimination improvement(IDI),and continuous net reclassification improvement(c NRI).A total of 11,360 patients(male,n=6,024(53.0%)were included in the final study cohort,and 6,363 patients had malnutrition based on PG-SGA.Based on AIWW,NRS-2002,and MST,7,545,3,469,and1,840 patients were at risk of malnutrition,respectively.The sensitivities of AIWW,NRS-2002,and MST risks were 0.910,0.531,and 0.285,and the specificities were 0.768,0.946,and 0.975.The Kendall tau coefficients of AIWW,NRS-2002,and MST risks were 0.588,0.501,and 0.326,respectively.The area under the curve of AIWW,NRS-2002,and MST risks were0.785,0.739,and 0.630,respectively.The IDI,c NRI,and DCA showed that AIWW is non-inferior to NRS-2002(IDI:0.002(-0.009,0.013),c NRI:-0.015(-0.049,0.020)).AIWW scores can also predict the survival of patients with cancer.The missed diagnosis rates of AIWW,NRS-2002,and MST were 0.09%,49.0%,and 73.2%,respectively.AIWW showed a better nutritionscreening effect than NRS-2002 and MST for patients with cancer and could be recommended as an alternative nutritionscreening tool for this population.