Spots Global Cancer Trial Database for To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer
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Trial Identification
Brief Title: To Test the Food for Special Medical Purpose in Perioperative Patients With Gastrointestinal Cancer
Official Title: Efficacy and Safety of Fresubin Support Drink for Enteral Nutrition Support in Perioperative Patients With Gastrointestinal Cancer: A Prospective, Randomized, Open-Label, Active-Controlled Multi-Center Clinical Trial
Study ID: NCT05606848
Conditions
Study Description
Brief Summary: This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. Aim of the study is to evaluate the efficacy and safety of Fresubin Support Drink in patients with gastrointestinal cancer undergoing surgical resection during the perioperative period.
Detailed Description: This is a prospective, randomized, open label, active-controlled, multi-centre, non-inferiority clinical trial. The IMP includes study product and control product. The study product will be Fresubin Support Drink (FSMP), the control product will be Enteral Nutrition Emulsion(TPF-T) . 250 patients will be randomly assigned to the Fresubin Support Drink (FSMP) group or Enteral Nutrition Emulsion(TPF-T) group at a ratio of 1:1. Prealbumin, albumin, C-reactive protein (CRP), immunology parameters, vital signs, nutrition and safety-related laboratory parameters, compliance, and Adverse Events (AEs) will be evaluated in this study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Beijing Hospital, Beijing, , China
Beijing Cancer Hospital, Beijing, , China
Capital Medical University Affiliated Beijing Shijitan Hospital, Beijing, , China
Peking University People's Hospital, Beijing, , China
Xiangya Hospital Central South University, Changsha, , China
The First Affiliated Hospital Of Guangzhou Medical University, Guangzhou, , China
Nanfang Hospital, Guanzhou, , China
Yunnan Cancer Hospital（The affiliated hospital of Kunming medical university）, Kunming, , China
Jiangsu Province Hospital of Chinese Medicine, Nanjing, , China
The Affiliated Hospital of Qingdao University, Qingdao, , China
The Fourth Hospital of Hebei Medical University （Hebei Tumor Hospital）, Shijia Zhuang, , China
The First Affiliated Hospital of SOOCHOW University, Suzhou, , China
The Central Hospital of Wuhan, Wuhan, , China
Union hospital tongji medical college huazhong university of science and technology, Wuhan, , China
Contact Details
Name: Hanping Shi, MD
Affiliation: Capital Medical University Affiliated Beijing Shijitan Hospital
Role: PRINCIPAL_INVESTIGATOR
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