search
Back to results

Therapy of Radiation Enteritis With Glutamine

Primary Purpose

Radiation Enteritis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Glutamine
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiation Enteritis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of chronic radiation enteritis
  • Need the operation
  • Malnutrition

Exclusion Criteria:

  • Hepatic failure
  • Kidney failure
  • Neoplasm recurrence
  • Serious cardiovascular/metabolic disease
  • Pregnancy and lactation

Sites / Locations

  • Department of Surgery, Nanjing General Hospital of Nanjing Command

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

placebo group

Glutamine group

Arm Description

Outcomes

Primary Outcome Measures

inflammatory factor

Secondary Outcome Measures

Full Information

First Posted
December 27, 2012
Last Updated
January 3, 2013
Sponsor
Nanjing University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT01758783
Brief Title
Therapy of Radiation Enteritis With Glutamine
Official Title
the Efficacy of Glutamine in the Therapy of Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective: To evaluate the effects of perioperative glutamine supplemented total parenteral nutrition support on nutritional status, immunologic function and intestinal permeability of patients with chronic radiation intestinal injury. Methods: The 40 patients with CRII were randomized into two groups, the standard TPN group and glutamine-enriched TPN group. The patients were administered total parenteral nutrition for at least four weeks (two weeks pre-operation and two weeks post-operation). The nutritional status, immunologic function, plasma concentration of glutamine and intestinal permeability were measured at 1 day, 1 week and 2 weeks pre-operation, 3 day, 1 week and 2 weeks post-operation. Nutrition status was determined the plasma concentrations of hemoglobin, albumin, prealbumin, transferrin and triglyceride. Immunologic function were measured by the percentages of CD4+T cells and CD8+T cells, the ratio of CD4 +T cells to CD8+T cells ( CD4 +/CD8 +) was calculated, and serum IgA, IgM and IgG.The intestinal permeability was detected by the urinal ratio of lactulose and mannitol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Enteritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Title
Glutamine group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Glutamine
Intervention Description
amino acid:1.2-2g/(kg·d) Glutamine:0.5g /(kg·d)
Primary Outcome Measure Information:
Title
inflammatory factor
Time Frame
2 weeks after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of chronic radiation enteritis Need the operation Malnutrition Exclusion Criteria: Hepatic failure Kidney failure Neoplasm recurrence Serious cardiovascular/metabolic disease Pregnancy and lactation
Facility Information:
Facility Name
Department of Surgery, Nanjing General Hospital of Nanjing Command
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Learn more about this trial

Therapy of Radiation Enteritis With Glutamine

We'll reach out to this number within 24 hrs