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.