Biological Assessment of Clinical Nutrition and Its Application

Malnutrition Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02102659
• Other study ID #: TJ-20130803
• Status: Active, not recruiting
• Phase: N/A
• First received: November 27, 2013
• Last updated: April 2, 2014
• Start date: March 2014
• Est. completion date: November 2015

Study information

• Verified date: March 2014
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

1. Clinical nutritional support therapy is an important progress of modern medicine.

2. 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.

3. 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.

4. 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.

5. 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".

6. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 167
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients with Gastric cancer or colorectal cancer which confirmed by Preoperative pathology will be included.

2. Patients who are diagnosed as malnutrition according history, physical examination and Nutrition Risk Screening 2002 will be included.

3. patients who have digestive tract fistula because of operation complication will be included.

4. patients who need fast track recovery after colorectal cancer operation will be included.

Exclusion Criteria:

1. Patients who are diagnosed as Late stage (stage IV) gastric cancer or colorectal cancer and can not accomplish radical resection will be excluded.

2. 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.

3. patients with Severe endocrine system disease such as diabetic mellitus, hyperthyroidism will be excluded.

4. patients with cardiac, renal, respiratory, or hepatic diseases, diabetes,active infection, evidence of sepsis, active bleeding or obstruction, and oral disease will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malnutrition

Intervention

Genetic:
• Upper Limit Nutrition Support Therapy
"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
"Formula nutrition support therapy" will be used in patens assigned in this group based on Harris Bendiest Formula.

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College in Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

References & Publications (8)

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):680-5. doi: 10.10 — View 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. — View 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. — View Citation

Li C, Thompson CB. Cancer. DNA damage, deamidation, and death. Science. 2002 Nov 15;298(5597):1346-7. — View 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. Epub 2006 Sep 15. — View Citation

Norman K, Pichard C, Lochs H, Pirlich M. Prognostic impact of disease-related malnutrition. Clin Nutr. 2008 Feb;27(1):5-15. Epub 2007 Dec 3. Review. — View Citation

Schiesser M, Müller S, Kirchhoff P, Breitenstein S, Schäfer 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2nd day	Yes
Primary	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.	9th day	Yes
Secondary	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.	10 or 12 days	Yes
Secondary	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..	9 days	Yes
Secondary	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.	9 days	No