NCT01549782

Brief Summary

Abdominal and pelvic radiotherapy (RT) reduces the renewal capacity of the epithelium. Rectal biopsies obtained from patients receiving pelvic RT have revealed atrophy of surface epithelium, acute cryptitis, crypt abscesses, crypt distortion and atrophy, and stromal inflammation. Modifications in intestinal microbiota, such as an increase in the number of pathogens, may contribute to intestinal injury. The prebiotic effect of a carbohydrate is assessed by its capacity to stimulate the proliferation of healthy bacteria (Bifidobacterium, Lactobacillus) rather than pathogenic bacteria (Clostridium, E. coli). The hypothesis of the study is that a mixture of inulin and fructooligosaccharide could modulate Lactobacillus and Bifidobacterium and reduce the intestinal injury in patients affected of gynaecological cancer and treated with abdominal radiotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

2.5 years

First QC Date

March 7, 2012

Last Update Submit

March 8, 2012

Conditions

PrebioticsMicrobiotaRadiation Therapy ComplicationEndometrial Neoplasms

Keywords

PrebioticsMicrobiotaRadiotherapyGynaecological Cancer

Outcome Measures

Primary Outcomes (1)

  • Changes in Lactobacillus and Bifidobacterium populations

    2 months

Secondary Outcomes (1)

  • Changes in calprotectin and DNA levels.

    2 months

Study Arms (2)

Fiber supplement

ACTIVE COMPARATOR

6 gr daily of fibre (50% inulin and 50% FOS). Patients underwent a 1-week run-in period before starting RT and continued taking the same products throughout the treatment course, until three weeks after RT was finished.

Dietary Supplement: Inulin and Fructo-oligosaccharide

Maltodextrine

PLACEBO COMPARATOR

6 gr daily of maltodextrine. Patients underwent a 1-week run-in period before starting RT and continued taking the same products throughout the treatment course, until three weeks after RT was finished.

Dietary Supplement: Maltodextrine

Interventions

Inulin and Fructo-oligosaccharideDIETARY_SUPPLEMENT

6 gr daily of fibre (50% inulin and 50% FOS). Patients underwent a 1-week run-in period before starting RT and continued taking the same products throughout the treatment course, until three weeks after RT was finished.

Fiber supplement
MaltodextrineDIETARY_SUPPLEMENT

6 gr daily of maltodextrine. Patients underwent a 1-week run-in period before starting RT and continued taking the same products throughout the treatment course, until three weeks after RT was finished.

Maltodextrine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female gender, age ≥ 18 years, and a diagnosis of gynaecologic cancer requiring postoperative pelvic RT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrition Unit. HGU Gregorio Marañón

Madrid, Madrid, 28007, Spain

Location

Related Publications (1)

  • Garcia-Peris P, Velasco C, Lozano MA, Moreno Y, Paron L, de la Cuerda C, Breton I, Camblor M, Garcia-Hernandez J, Guarner F, Hernandez M. Effect of a mixture of inulin and fructo-oligosaccharide on Lactobacillus and Bifidobacterium intestinal microbiota of patients receiving radiotherapy: a randomised, double-blind, placebo-controlled trial. Nutr Hosp. 2012 Nov-Dec;27(6):1908-15. doi: 10.3305/nh.2012.27.6.5992.

    PMID: 23588438DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Inulin

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

StarchGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesFructansPolysaccharides

Study Officials

  • Pilar Garcia-Peris, PhD

    Nutrition Unit. HGU Gregorio Maranon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Endocrinologist.

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 9, 2012

Study Start

June 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

ES(1)