Investigation on nutrition status and clinical outcome of patients with common cancers in Chinese patients: a multicenter prospective study protocol
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.
Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016;66(1):7-30.
Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, et al. Cancer statistics in China, 2015. CA Cancer J Clin. 2016;66(2):115-32.
Miller KD, Siegel RL, Lin CC, Mariotto AB, Kramer JL, Rowland JH, et al. Cancer treatment and survivorship statistics, 2016. CA Cancer J Clin. 2016;66(4):271-89.
Virizuela JA, Camblor-Álvarez M, Luengo-Pérez LM, Grande E, Álvarez-Hernández J, Sendrós-Madroño MJ, et al. Nutritional support and parenteral nutrition in cancer patients: an expert consensus report. Clin Transl Oncol. 2018;20(5):619-29.
Argilés JM. Cancer-associated malnutrition. Eur J Oncol Nurs. 2005;9(Suppl 2):S39-50.
Omlin A, Blum D, Wierecky J, Haile SR, Ottery FD, Strasser F. Nutrition impact symptoms in advanced cancer patients: frequency and specific interventions, a case-control study. J Cachexia Sarcopenia Muscle. 2013;4(1):55-61.
Obermair A, Simunovic M, Isenring L, Janda M. Nutrition interventions in patients with gynecological cancers requiring surgery. Gynecol Oncol. 2017;145(1):192-9.
Ravasco P, Monteiro-Grillo I, Vidal PM, Camilo ME. Dietary counseling improves patient outcomes: a prospective, randomized, controlled trial in colorectal cancer patients undergoing radiotherapy. J Clin Oncol. 2005;23(7):1431-8.
Martin L, Lagergren J, Lindblad M, Rouvelas I, Lagergren P. Malnutrition after oesophageal cancer surgery in Sweden. Br J Surg. 2007;94(12):1496-500.
Rosania R, Chiapponi C, Malfertheiner P, Venerito M. Nutrition in Patients with Gastric Cancer: An Update. Gastrointest Tumors. 2016;2(4):178-87.
Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, et al. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017;36(1):11-48.
Waitzberg DL, Caiaffa WT, Correia MI. Hospital malnutrition: the Brazilian national survey (IBRANUTRI): a study of 4000 patients. Nutrition. 2001;17(7-8):573-80.
Ollenschläger G, Viell B, Thomas W, Konkol K, Bürger B. Tumor anorexia: causes, assessment, treatment. Recent Results Cancer Res. 1991;121:249-59.
Baldwin C, Weekes CE. Dietary advice for illness-related malnutrition in adults. Cochrane Database Syst Rev. 2008;1:CD002008.
Rivadeneira DE, Evoy D, Fahey TJ 3rd, Lieberman MD, Daly JM. Nutritional support of the cancer patient. CA Cancer J Clin. 1998;48(2):69-80.
Chima CS, Barco K, Dewitt ML, Maeda M, Teran JC, Mullen KD. Relationship of nutritional status to length of stay, hospital costs, and discharge status of patients hospitalized in the medicine service. J Am Diet Assoc. 1997;97(9):975-8.
Correia MI, Waitzberg DL. The impact of malnutrition on morbidity, mortality, length of hospital stay and costs evaluated through a multivariate model analysis. Clin Nutr. 2003;22(3):235-9.
Pressoir M, Desné S, Berchery D, Rossignol G, Poiree B, Meslier M, et al. Prevalence, risk factors and clinical implications of malnutrition in French Comprehensive Cancer Centres. Br J Cancer. 2010;102(6):966-71.
Wie GA, Cho YA, Kim SY, Kim SM, Bae JM, Joung H. Prevalence and risk factors of malnutrition among cancer patients according to tumor location and stage in the National Cancer Center in Korea. Nutrition. 2010;26(3):263-8.
Sesterhenn AM, Szalay A, Zimmermann AP, Werner JA, Barth PJ, Wiegand S. Significance of autopsy in patients with head and neck cancer. Laryngorhinootologie. 2012;91(6):375-80.
Zhang L, Lu Y, Fang Y. Nutritional status and related factors of patients with advanced gastrointestinal cancer. Br J Nutr. 2014;111(7):1239-44.
Caillet P, Liuu E, Raynaud Simon A, Bonnefoy M, Guerin O, Berrut G, et al. Association between cachexia, chemotherapy and outcomes in older cancer patients: A systematic review. Clin Nutr. 2017;36(6):1473-82.
Ottery FD. Rethinking nutritional support of the cancer patient: the new field of nutritional oncology. Semin Oncol. 1994;21(6):770-8.
Ravasco P, Monteiro-Grillo I, Camilo M. Individualized nutrition intervention is of major benefit to colorectal cancer patients: long-term follow-up of a randomized controlled trial of nutritional therapy. Am J Clin Nutr. 2012;96(6):1346-53.
Temel JS, Greer JA, Muzikansky A, Gallagher ER, Admane S, Jackson VA, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl J Med. 2010;363(8):733-42.
Baldwin C, Spiro A, Ahern R, Emery PW. Oral nutritional interventions in malnourished patients with cancer: a systematic review and meta-analysis. J Natl Cancer Inst. 2012;104(5):371-85.
Barlow R, Price P, Reid TD, Hunt S, Clark GW, Havard TJ, Puntis MC, Lewis WG. Prospective multicentre randomised controlled trial of early enteral nutrition for patients undergoing major upper gastrointestinal surgical resection. Clin Nutr. 2011;30(5):560-6.
Wu GH, Liu ZH, Wu ZH, Wu ZG. Perioperative artificial nutrition in malnourished gastrointestinal cancer patients. World J Gastroenterol. 2006;12(15):2441-4.
Chi J, Yin S, Zhu Y, Gao F, Song X, Song Z, Lv J, Li M. A Comparison of the Nutritional Risk Screening 2002 Tool With the Subjective Global Assessment Tool to Detect Nutritional Status in Chinese Patients Undergoing Surgery With Gastrointestinal Cancer. Gastroenterol Nurs. 2017;40(1):19-25.
Yu K, Zhou XR, He SL. A multicentre study to implement nutritional risk screening and evaluate clinical outcome and quality of life in patients with cancer. Eur J Clin Nutr. 2013;67(7):732-7.
Zhang L, Wang C, Sha SY, Kwauk S, Miller AR, Xie MS, et al. Mini-nutrition assessment, malnutrition, and postoperative complications in elderly Chinese patients with lung cancer. J BUON. 2012;17(2):323-6.
Wu B, Yin TT, Cao W, Gu ZD, Wang X, Yan M, et al. Validation of the Chinese version of the Subjective Global Assessment scale of nutritional status in a sample of patients with gastrointestinal cancer. Int J Nurs Stud. 2010;47(3):323-31.
Cong M, Wang J, Fang Y, Liu Y, Sun M, Wu Q, et al. A multi-center survey on dietary knowledge and behavior among inpatients in oncology department. Support Care Cancer. 2018;26(7):2285-92.
Wu BW, Yin T, Cao WX, Gu ZD, Wang XJ, Yan M, et al. Clinical application of subjective global assessment in Chinese patients with gastrointestinal cancer. World J Gastroenterol. 2009;15(28):3542-9.
Kondrup J, Rasmussen HH, Hamberg O, Stanga Z, Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003;22(3):321-36.
Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993;85(5):365-76.
Fayers PMANK, Bjorda lKN, JLKDJAOI. On behalf of the EORTC Quality of Life Group. The EORTC QLQ-C30 Scoring Manual (3rd Edition). 2001.
Lochs H, Allison SP, Meier R, Pirlich M, Kondrup J, Schneider S, et al. Introductory to the ESPEN Guidelines on Enteral Nutrition: Terminology, definitions and general topics. Clin Nutr. 2006;25(2):180-6.
Buzby GP, Knox LS, Crosby LO, Eisenberg JM, Haakenson CM, McNeal GE, et al. Study protocol: a randomized clinical trial of total parenteral nutrition in malnourished surgical patients. Am J Clin Nutr. 1988;47(2 Suppl):366-81.