Spots Global Cancer Trial Database for Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer
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Trial Identification
Brief Title: Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer
Official Title: Effects of Immunonutrition (Impact Oral®) in Patients Undergoing Surgery for Gastrointestinal Cancer
Study ID: NCT03665714
Conditions
Study Description
Brief Summary: This study will evaluate the efficacy and safety of Impact Oral in Patients undergoing Surgery for Gastrointestinal Cancer, half of the participants will receive Impact Oral nutrition therapy, the other half will receive Enteral Nutrition Emulsion(TPF-T) therapy.
Detailed Description: The present protocol describes a randomized, active-controlled, open labelled study in which either IMPACT Oral or Enteral Nutrition Emulsion(TPF-T) will be given to surgical patients for 5 days before surgery and 7 days after surgery. Both of the study products include immunonutrition, but the nutrient proportion is different. Prealbumin, C-reaction protein (CRP), Albumin，immunology parameters, the results of physical examination, vital signs, relevant nutrition- and safety-related laboratory parameters and the number, severity, seriousness, relatedness and outcome of 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
Peiking Union Medical College Hospital, Beijing, Beijing, China
Contact Details
Name: Jianchun Yu, MD
Affiliation: Peiking Union Medical College Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Gang Xiao, MD
Affiliation: Beijing Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Yingjiang Ye, MD
Affiliation: Peiking University People's Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Baogui Wang, MD
Affiliation: Tianjin Tumor Hospital
Role: PRINCIPAL_INVESTIGATOR
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