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Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.


Phase 4
18 Years
N/A
Not Enrolling
Both
Acute Radiation Enteritis

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Trial Information

Efficacy of Glutamine in the Prevention of Acute Radiation Enteritis Among Patients Treated With Radiation of Abdomen and Pelvis.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Number of patients with acute radiation enteritis

Outcome Description:

RTOG criteria

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Alfonso Vidal Casariego, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sección de Endocrinología y Nutrición. Complejo Asistencial de León

Authority:

Spain: Ethics Committee

Study ID:

001-2008-BecaSacyl

NCT ID:

NCT00828399

Start Date:

January 2009

Completion Date:

May 2011

Related Keywords:

  • Acute Radiation Enteritis
  • Radiotherapy
  • Diarrhoea
  • Glutamine
  • Oxydative stress
  • Calprotectin
  • Citrulline
  • Enteritis

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