ProtocolInternational Journal of Clinical Trials
Publication: Investigation on nutrition status and clinical outcome of patients with common cancers in Chinese patients: a multicenter prospective study protocol
Int J Clin Trials. 2020;7(2):94-102.DOI10.18203/2349-3259.ijct20201052
Abstract
Background Malnutrition is common in patients with cancer, which adversely affects the survival and quality of life of cancer patients. However, there is no national data on the prevalence of malnutrition in Chinese cancer patients. This study aims to evaluate the prevalence of malnutrition and quality of life (QOL) of Chinese patients with local regional, recurrent or metastatic cancer, to address the prognostic value of nutritional status and QOL on the survival of cancer patients in China and to validate the patient-generated subjective global assessment (PG-SGA) questionnaire in Chinese cancer patients.
Methods This is an observational, multi-centered, and hospital-based prospective cohort study. We aimed to recruit 50,000 cancer patients (age 18 and above) over an 8-year period. Data collection will occur within 48 hr after patients are admitted to hospital, 30-days after hospital admission, and the follow-up will be conducted 1-8 years after enrolment. The primary outcome is overall survival, and secondary outcomes are length of hospital stay and hospital costs. Factors measured are demographic characteristics, tumor characteristics, anthropometry measurements, hematological measurement, body composition, PG-SGA scores, Karnofsky performance status scores, and QLQ C30 scores. This protocol was approved by local ethical committees of all the participant hospitals.
Conclusions This multi-centered, large-scale, long-time follow-up prospective study will help diagnose malnutrition in cancer patients in China, and identify the related risk factors associated with the negative outcomes. The anticipated results will highlight the need for a truly scientific appraisal of nutrition therapy, and help to improve outcomes among cancer patients in China.Trial Registration: The trial has been registered with the Chinese Clinical Trial Registry, ChiCTR1800020329. Registered on 19 December 2018.
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Affiliations
- Department of Clinical Nutrition, Daping Hospital, Army Medical University, Chongqing, China
- Department of Epidemiology, College of Public Health, Zhengzhou University, Zhengzhou, Henan, China
- Cancer Center, The First Hospital of Jilin University, Changchun, Jilin, China
- Cancer Center, Renmin Hospital of Wuhan University, Wuhan, Hubei, China
- Department of Medical Oncology, Fujian Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, Fujian, China
- Department of Gastrointestinal Surgery, Affiliated Cancer Hospital of Guangxi Medical University, Nanning, Guangxi, China
- Department of Surgery, The First Affiliated Hospital of SunYat-sen University, Guangzhou, Guangdong, China
- Department of Clinical Nutrition, West China Hospital of Sichuan University, Chengdu, Sichuan, China
- Department of Gastrointestinal Oncology, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin Key Laboratory of Cancer Prevention and Therapy, Tianjin, China
- Department of Nutrition and Metabolism of Oncology, Affiliated Provincial Hospital of Anhui Medical University, Hefei, Anhui, China
- Department of Clinical Nutrition, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China
- Department of Gastrointestinal Surgery, Institute of Gastroenterology, The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
- Department of Clinical Nutrition, The First People's Hospital of Kashi, Xinjiang, China
- Department of Clinical Nutrition, Chongqing General Hospital, Chongqing, China
- Department of Colorectal and Anal Surgery, Huizhou Municipal Central Hospital, Huizhou, Guangdong, China
- Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
- Department of Oncology, Xingtai People’s Hospital, Hebei Medical University, Xingtai, Hebei, China
- Harbin Medical University Cancer Hospital, Harbin, Heilongjiang, China
- Department of Nutrition, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, Guangdong, China
- Department of Oncology, Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, Henan, China
- Department of General Surgery, Xiangya Hospital, Central South University, Changsha, Hunan, China
- Comprehensive Oncology Department, National Cancer Center or Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
- Department of Oncology, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, China
- The Fourth Affiliated Hospital, Harbin Medical University, Harbin, Heilongjiang, China
- Cancer center, The First People's Hospital of Foshan, Foshan, Guangdong, China,
- Department of Gastrointestinal Tumor Surgery, The First Affiliated Hospital, Xiamen University, Xiamen, Fujian, China
- Department of Nutrition, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China
- Department of Nutrition, Tianjin Third Central Hospital, Tianjin, China
- Department of Surgery, The First Affiliated Hospital of Jinan University, Guangzhou, Guangdong, China
- Department of General Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing, Jiangsu, China
- Department of Gastrointestinal Surgery, First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
- Department of Radiation and Medical Oncology, People's Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China
- Department of Clinical Nutrition, Peking University Cancer Hospital and Institute, Beijing, China
- Department of Nutrition, Third Affiliated Hospital of Kunming Medical College, Tumor Hospital of Yunnan Province, Kunming, Yunnan, China
- Department of Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
- Department of Nutrition, Guangzhou Red Cross Hospital, Guangzhou, Guangdong, China
- Department of Radiotherapy, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, School of Medicine, University of Electronic Science and Technology of China Chengdu, Sichuan, China
- Department of Clinical Nutrition, Clifford Hospital, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China
- Department of Digestive Diseases, Xijing Hospital, Fourth Military Medical University, Xi'an, Shanxi, China
- Department of Hepatobiliary Surgery, National Cancer Center or Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China
- Department of Clinical Nutrition, The First Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China
- Department of Integrated Traditional Chinese and Western Medicine, Zhejiang Cancer Hospital and Key Laboratory of Traditional Chinese Medicine Oncology, Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
- Department of Gastrointestinal Surgery, Department of Clinical Nutrition, Beijing Shijitan Hospital, Beijing, China, Department of Oncology, Capital Medical University or Ninth Clinical Medical College, Peking University, Beijing, China