Prevention of Acute Radiation Enteritis With Glutamine | NCT00828399

Studies
Prevention of Acute Radiation Enteritis With Glutamine

NCT00828399

Sponsor

Castilla-León Health Service

Status

Completed

Last Update Posted

May 25, 2011Estimated

Enrollment

70Actual

Phase

Phase 4

Conditions

Acute Radiation Enteritis

Interventions

Glutamine
Whole protein

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

May 2011Actual

Completion Date

May 2011Actual

First Submitted Date

Jan 22, 2009

First Submission Date that Met QC Criteria

Jan 22, 2009

First Posted Date

Jan 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 24, 2011

Last Update Posted Date

May 25, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glutamine	Experimental		Dietary Supplement: Glutamine
Whole protein	Placebo Comparator		Dietary Supplement: Whole protein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glutamine	Dietary Supplement	Oral glutamine 30g/day	Glutamine
Whole protein

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients with acute radiation enteritis	RTOG criteria	2 months

Secondary Outcomes

Measure	Description	Time Frame
Reduction in inflammatory markers and oxydative stress		2 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alfonso Vidal Casariego, MD	Sección de Endocrinología y Nutrición. Complejo Asistencial de León	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Complejo Asistencial de León.		León	Leon	24008	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12721240	Result	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.
16531144

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D024361	Amino Acids, Basic
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins
D000599	Amino Acids, Diamino