Prevention of Acute Radiation Enteritis With Glutamine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Radiation Enteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Glutamine

Group Type EXPERIMENTAL

Glutamine

Intervention Type DIETARY_SUPPLEMENT

Oral glutamine 30g/day

Whole protein

Group Type PLACEBO_COMPARATOR

Whole protein

Intervention Type DIETARY_SUPPLEMENT

Oral whole protein 30 g/day

Interventions

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Glutamine

Oral glutamine 30g/day

Intervention Type DIETARY_SUPPLEMENT

Whole protein

Oral whole protein 30 g/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No