Biological Assessment of Clinical Nutrition and Its Application
Primary Purpose
Malnutrition
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Upper Limit Nutrition Support Therapy
Formula Nutrition Support Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition focused on measuring Nutritional Assessment, Oral Epithelial Cell, Apoptosis
Eligibility Criteria
Inclusion Criteria:
- Patients with Gastric cancer or colorectal cancer which confirmed by Preoperative pathology will be included.
- Patients who are diagnosed as malnutrition according history, physical examination and Nutrition Risk Screening 2002 will be included.
- patients who have digestive tract fistula because of operation complication will be included.
- patients who need fast track recovery after colorectal cancer operation will be included.
Exclusion Criteria:
- Patients who are diagnosed as Late stage (stage IV) gastric cancer or colorectal cancer and can not accomplish radical resection will be excluded.
- Postoperative gastric cancer or colorectal cancer patients who is Unable to tolerate the chemotherapy or unable to complete the whole chemotherapy course will be excluded.
- patients with Severe endocrine system disease such as diabetic mellitus, hyperthyroidism will be excluded.
- patients with cardiac, renal, respiratory, or hepatic diseases, diabetes,active infection, evidence of sepsis, active bleeding or obstruction, and oral disease will be excluded.
Sites / Locations
- Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Upper Limit Nutrition Support Therapy
Formula Nutrition Support Therapy
Arm Description
"Upper limit nutrition support therapy" will be used in patens assigned to this group based on the patient's curve of apoptosis of oral mucosal epithelium.
"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.
Outcomes
Primary Outcome Measures
The Length and Width of Surgical Incision Edema
The length and width of surgical incision edema will be measured by doppler ultrasonography in the 2nd day respectively after gastrointestinal operation.
The Length and Width of Surgical Incision Edema
The length and width of surgical incision edema will be measured by doppler ultrasonography in the 9th day respectively after gastrointestinal operation.
Secondary Outcome Measures
Oral Mucosal Epithelial Cell Apoptosis Rate
Oral mucosal epithelial cell samples will be collected in the every morning before tooth brushing teeth for 9 days after gastrointestinal operation..The cells well be analyzed by flow cytometry for detecting apoptosis rate.
Anthropometric measurements
Anthropometric measurements including weight, body mass index, triceps skinfold thickness, and midarm muscle circumference will be recorded every 2-3 days days for 9 days after gastrointestinal operation..
The level of serum proteins
The serum proteins including retinol-binding protein (RBP), transferrin, prealbumin (PA), and albumin will be measured every 2-3 days for 9 days after gastrointestinal operation.
Full Information
NCT ID
NCT02102659
First Posted
November 27, 2013
Last Updated
April 2, 2014
Sponsor
Huazhong University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02102659
Brief Title
Biological Assessment of Clinical Nutrition and Its Application
Official Title
This Preliminary Study Was Designed to Explore a New Biological Method for Nutritional Assessment by Measuring Oral Mucosal Epithelial Cell Apoptosis Rate and Guideline to Clinical Nutrition Support Therapy for Improving Clinical Outcome of Malnourished Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
November 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical nutritional support therapy is an important progress of modern medicine.
Conventional methods of clinical nutrition assessment (Anthropometric, lab, etc.) not just lack of accuracy and immediacy but also difficult to dynamically reflect the fluctuation trend of nutrition status.
It has been reported that malnutrition affects proliferation and apoptosis of human cells in vivo. This preliminary study was initiated by the hypothesis that changes in nutritional status may be reflected rapidly in fast proliferating cells.
In the previous studies the investigators already found that apoptosis rate of oral mucosal epithelium could reflect changes in nutritional status.There were an obvious decreasing in apoptosis and proliferation rate of oral mucosal epithelium in malnourished patients.
Based on the patient's curve of apoptosis rate of oral mucosal epithelium, the plateau being achieved by increase the nutrition amount continuously, Maintain this amount of nutrition given until the end of treatment. The investigators call this amount of nutrition the "upper limit nutrition support therapy".
The patients applying for"upper limit nutrition support therapy" and "Formula nutrition support therapy" separately, comparing of the two methods influences on postoperative wound healing, postoperative complication rate ,inflammatory response, side effects of chemotherapy, hospital stays and hospitalization expenses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition
Keywords
Nutritional Assessment, Oral Epithelial Cell, Apoptosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
167 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Upper Limit Nutrition Support Therapy
Arm Type
Experimental
Arm Description
"Upper limit nutrition support therapy" will be used in patens assigned to this group based on the patient's curve of apoptosis of oral mucosal epithelium.
Arm Title
Formula Nutrition Support Therapy
Arm Type
Active Comparator
Arm Description
"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.
Intervention Type
Genetic
Intervention Name(s)
Upper Limit Nutrition Support Therapy
Other Intervention Name(s)
Apoptosis rate of human oral epithelial cells
Intervention Description
"Upper limit nutrition support therapy" will be used in patens assigned to this group based on the patient's curve of apoptosis of oral mucosal epithelium
Intervention Type
Genetic
Intervention Name(s)
Formula Nutrition Support Therapy
Intervention Description
"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.
Primary Outcome Measure Information:
Title
The Length and Width of Surgical Incision Edema
Description
The length and width of surgical incision edema will be measured by doppler ultrasonography in the 2nd day respectively after gastrointestinal operation.
Time Frame
2nd day
Title
The Length and Width of Surgical Incision Edema
Description
The length and width of surgical incision edema will be measured by doppler ultrasonography in the 9th day respectively after gastrointestinal operation.
Time Frame
9th day
Secondary Outcome Measure Information:
Title
Oral Mucosal Epithelial Cell Apoptosis Rate
Description
Oral mucosal epithelial cell samples will be collected in the every morning before tooth brushing teeth for 9 days after gastrointestinal operation..The cells well be analyzed by flow cytometry for detecting apoptosis rate.
Time Frame
10 or 12 days
Title
Anthropometric measurements
Description
Anthropometric measurements including weight, body mass index, triceps skinfold thickness, and midarm muscle circumference will be recorded every 2-3 days days for 9 days after gastrointestinal operation..
Time Frame
9 days
Title
The level of serum proteins
Description
The serum proteins including retinol-binding protein (RBP), transferrin, prealbumin (PA), and albumin will be measured every 2-3 days for 9 days after gastrointestinal operation.
Time Frame
9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with Gastric cancer or colorectal cancer which confirmed by Preoperative pathology will be included.
Patients who are diagnosed as malnutrition according history, physical examination and Nutrition Risk Screening 2002 will be included.
patients who have digestive tract fistula because of operation complication will be included.
patients who need fast track recovery after colorectal cancer operation will be included.
Exclusion Criteria:
Patients who are diagnosed as Late stage (stage IV) gastric cancer or colorectal cancer and can not accomplish radical resection will be excluded.
Postoperative gastric cancer or colorectal cancer patients who is Unable to tolerate the chemotherapy or unable to complete the whole chemotherapy course will be excluded.
patients with Severe endocrine system disease such as diabetic mellitus, hyperthyroidism will be excluded.
patients with cardiac, renal, respiratory, or hepatic diseases, diabetes,active infection, evidence of sepsis, active bleeding or obstruction, and oral disease will be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianping Gong, M.D.,Ph.D.
Organizational Affiliation
Huazhong University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
11680474
Citation
Studley HO. Percentage of weight loss: a basic indicator of surgical risk in patients with chronic peptic ulcer. 1936. Nutr Hosp. 2001 Jul-Aug;16(4):141-3; discussion 140-1. No abstract available.
Results Reference
background
PubMed Identifier
18342995
Citation
Schiesser M, Muller S, Kirchhoff P, Breitenstein S, Schafer M, Clavien PA. Assessment of a novel screening score for nutritional risk in predicting complications in gastro-intestinal surgery. Clin Nutr. 2008 Aug;27(4):565-70. doi: 10.1016/j.clnu.2008.01.010. Epub 2008 Mar 17.
Results Reference
background
PubMed Identifier
18061312
Citation
Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. doi: 10.1016/j.clnu.2007.10.007. Epub 2007 Dec 3.
Results Reference
background
PubMed Identifier
7776363
Citation
Jones JS, Tidwell B, Travis J, Spencer T, Phillips P, Burford B. Nutritional support of the hospitalized patient: a team approach. J Miss State Med Assoc. 1995 Apr;36(4):91-9.
Results Reference
background
PubMed Identifier
12434041
Citation
Li C, Thompson CB. Cancer. DNA damage, deamidation, and death. Science. 2002 Nov 15;298(5597):1346-7. doi: 10.1126/science.1079168. No abstract available.
Results Reference
background
PubMed Identifier
8074286
Citation
Gong J, Traganos F, Darzynkiewicz Z. A selective procedure for DNA extraction from apoptotic cells applicable for gel electrophoresis and flow cytometry. Anal Biochem. 1994 May 1;218(2):314-9. doi: 10.1006/abio.1994.1184.
Results Reference
background
PubMed Identifier
23073796
Citation
Gao C, Hasan O, Wei X, Zou Y, Yin X, Tao D, Gong J. Assessment of nutritional status of clinical patients by determining normal range of oral mucosal apoptosis and proliferation rate. J Huazhong Univ Sci Technolog Med Sci. 2012 Oct;32(5):680-685. doi: 10.1007/s11596-012-1017-3. Epub 2012 Oct 18.
Results Reference
result
PubMed Identifier
16979323
Citation
Luo X, Zhou Y, Tao D, Yu Y, Hu J, Qiu F, Kulkarni H, Gong J. Usefulness of oral mucosal epithelial cell apoptosis rate in nutritional assessment. Nutrition. 2006 Oct;22(10):1032-8. doi: 10.1016/j.nut.2006.03.016. Epub 2006 Sep 15.
Results Reference
result
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Biological Assessment of Clinical Nutrition and Its Application
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