Prevention of Acute Radiation Enteritis With Glutamine

Sponsor

Castilla-León Health Service (Other)

Overall Status

Completed

CT.gov ID

NCT00828399

Collaborator

(none)

Enrollment

Location

Arms

27.9

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Radiation Enteritis	Dietary Supplement: Glutamine Dietary Supplement: Whole protein	Phase 4

Study Design

Study Type:

Interventional

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 :

Jan 1, 2009

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of patients with acute radiation enteritis [2 months]
RTOG criteria

Secondary Outcome Measures

Reduction in inflammatory markers and oxydative stress [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00828399

Other Study ID Numbers:

001-2008-BecaSacyl

First Posted:

Jan 23, 2009

Last Update Posted:

May 25, 2011

Last Verified:

Jan 1, 2009

Keywords provided by , ,

Additional relevant MeSH terms:

Enteritis

Study Results

No Results Posted as of May 25, 2011