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Prevention of Acute Radiation Enteritis With Glutamine

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ClinicalTrials.gov Identifier: NCT00828399
Recruitment Status : Completed
First Posted : January 23, 2009
Last Update Posted : May 25, 2011
Sponsor:
Information provided by:
Castilla-León Health Service

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.

Condition or disease Intervention/treatment Phase
Acute Radiation Enteritis Dietary Supplement: Glutamine Dietary Supplement: Whole protein Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.
Study Start Date : January 2009
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Glutamine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Glutamine Dietary Supplement: Glutamine
Oral glutamine 30g/day
Placebo Comparator: Whole protein Dietary Supplement: Whole protein
Oral whole protein 30 g/day



Primary Outcome Measures :
  1. Number of patients with acute radiation enteritis [ Time Frame: 2 months ]
    RTOG criteria


Secondary Outcome Measures :
  1. Reduction in inflammatory markers and oxydative stress [ Time Frame: 2 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828399


Locations
Spain
Complejo Asistencial de León.
Leon, Spain, 24008
Sponsors and Collaborators
Castilla-León Health Service
Investigators
Principal Investigator: Alfonso Vidal Casariego, MD Sección de Endocrinología y Nutrición. Complejo Asistencial de León

Publications:
Responsible Party: MD Alfonso Vidal Casariego, Complejo Asistencial de Leóm
ClinicalTrials.gov Identifier: NCT00828399     History of Changes
Other Study ID Numbers: 001-2008-BecaSacyl
First Posted: January 23, 2009    Key Record Dates
Last Update Posted: May 25, 2011
Last Verified: January 2009

Keywords provided by Castilla-León Health Service:
Radiotherapy
Diarrhoea
Glutamine
Oxydative stress
Calprotectin
Citrulline

Additional relevant MeSH terms:
Enteritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases