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Prevention of Acute Radiation Enteritis With Glutamine

Primary Purpose

Acute Radiation Enteritis

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Glutamine
Whole protein
Sponsored by
Castilla-León Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Radiation Enteritis focused on measuring Radiotherapy, Diarrhoea, Glutamine, Oxydative stress, Calprotectin, Citrulline

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > 18 yr
  • Gynaecological,prostatic, rectal or other abdominal cancer
  • Radiotherapy with/without chemotherapy

Exclusion Criteria:

  • life expectancy < 1 yr
  • Age < 18 yr
  • gut diseases: inflammatory bowel disease,sprue, irritable bowel disease...
  • moderate to severe chronic renal failure
  • hepatic cirrhosis

Sites / Locations

  • Complejo Asistencial de León.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Glutamine

Whole protein

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with acute radiation enteritis
RTOG criteria

Secondary Outcome Measures

Reduction in inflammatory markers and oxydative stress

Full Information

First Posted
January 22, 2009
Last Updated
May 24, 2011
Sponsor
Castilla-León Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT00828399
Brief Title
Prevention of Acute Radiation Enteritis With Glutamine
Official Title
Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Castilla-León Health Service

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Ionizing radiation has cytotoxic effects, and is commonly used as treatment for neoplasm. A common adverse effect of radiation is acute diarrhoea. Glutamine is an aminoacid with antioxidant effects that can protect tissues of damage dued to radiation. The investigators designed a randomized, double-blind trial phase III to study if glutamine prevents acute radiation enteritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Radiation Enteritis
Keywords
Radiotherapy, Diarrhoea, Glutamine, Oxydative stress, Calprotectin, Citrulline

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glutamine
Arm Type
Experimental
Arm Title
Whole protein
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Glutamine
Intervention Description
Oral glutamine 30g/day
Intervention Type
Dietary Supplement
Intervention Name(s)
Whole protein
Intervention Description
Oral whole protein 30 g/day
Primary Outcome Measure Information:
Title
Number of patients with acute radiation enteritis
Description
RTOG criteria
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Reduction in inflammatory markers and oxydative stress
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > 18 yr Gynaecological,prostatic, rectal or other abdominal cancer Radiotherapy with/without chemotherapy Exclusion Criteria: life expectancy < 1 yr Age < 18 yr gut diseases: inflammatory bowel disease,sprue, irritable bowel disease... moderate to severe chronic renal failure hepatic cirrhosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfonso Vidal Casariego, MD
Organizational Affiliation
Sección de Endocrinología y Nutrición. Complejo Asistencial de León
Official's Role
Principal Investigator
Facility Information:
Facility Name
Complejo Asistencial de León.
City
Leon
ZIP/Postal Code
24008
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
12721240
Citation
Kozelsky TF, Meyers GE, Sloan JA, Shanahan TG, Dick SJ, Moore RL, Engeler GP, Frank AR, McKone TK, Urias RE, Pilepich MV, Novotny PJ, Martenson JA; North Central Cancer Treatment Group. Phase III double-blind study of glutamine versus placebo for the prevention of acute diarrhea in patients receiving pelvic radiation therapy. J Clin Oncol. 2003 May 1;21(9):1669-74. doi: 10.1200/JCO.2003.05.060.
Results Reference
result
PubMed Identifier
16531144
Citation
Giris M, Erbil Y, Oztezcan S, Olgac V, Barbaros U, Deveci U, Kirgiz B, Uysal M, Toker GA. The effect of heme oxygenase-1 induction by glutamine on radiation-induced intestinal damage: the effect of heme oxygenase-1 on radiation enteritis. Am J Surg. 2006 Apr;191(4):503-9. doi: 10.1016/j.amjsurg.2005.11.004.
Results Reference
result
PubMed Identifier
10729239
Citation
Ersin S, Tuncyurek P, Esassolak M, Alkanat M, Buke C, Yilmaz M, Telefoncu A, Kose T. The prophylactic and therapeutic effects of glutamine- and arginine-enriched diets on radiation-induced enteritis in rats. J Surg Res. 2000 Apr;89(2):121-5. doi: 10.1006/jsre.1999.5808.
Results Reference
result
PubMed Identifier
15961682
Citation
de Urbina JJ, Jorquera F, Culebras JM, Villares C, Gonzalez-Gallego J, Tunon MJ. Effects of parenteral nutrition supplemented with alanyl-glutamine on nutrition status in rats. JPEN J Parenter Enteral Nutr. 2005 Jul-Aug;29(4):262-5. doi: 10.1177/0148607105029004262.
Results Reference
result

Learn more about this trial

Prevention of Acute Radiation Enteritis With Glutamine

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