NCT01170299

Brief Summary

RATIONALE: Fiber may lessen bowel side effects caused by radiation therapy. It is not yet known whether a high-fiber diet is more effective than a low-fiber diet in preventing bowel side effects caused by radiation therapy. PURPOSE: This randomized clinical trial is studying a high-fiber diet to see how well it works compared with a low-fiber diet in preventing bowel side effects in patients undergoing radiation therapy for gynecological cancer, bladder cancer, colorectal cancer, or anal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 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

October 1, 2009

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

November 1, 2016

Status Verified

July 1, 2010

Enrollment Period

3.2 years

First QC Date

July 24, 2010

Last Update Submit

October 31, 2016

Conditions

Anal CancerBladder CancerCervical CancerColorectal CancerFallopian Tube CancerGastrointestinal ComplicationsOvarian CancerRadiation ToxicitySarcoma

Keywords

radiation toxicitygastrointestinal complicationscervical cancerfallopian tube cancerovarian epithelial cancerovarian germ cell tumorovarian sarcomaovarian stromal canceruterine sarcomabladder cancercolon cancerrectal canceranal cancer

Outcome Measures

Primary Outcomes (1)

  • Change in IBDQ-B (Inflammatory Bowel Disease Questionnaire - Bowel Subset) score between baseline (i.e., Day 1 of radiotherapy treatment) and the nadir score during treatment

Secondary Outcomes (2)

  • Incidence of toxicity, defined using the Bristol Stool Chart

  • Costs for symptom management

Interventions

dietary interventionDIETARY_SUPPLEMENT
laboratory biomarker analysisOTHER
gastrointestinal complications management/preventionPROCEDURE
management of therapy complicationsPROCEDURE
selective external radiation therapyRADIATION

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of gynecological, urological (bladder), colorectal, or anal malignant cancer * Scheduled to undergo a course of radical or adjuvant pelvic radiotherapy (≥ 45 Gy) * Radiotherapy regimen will be delivered in daily fractions comprising approximately ≥ 25 fractions over 5-7 weeks PATIENT CHARACTERISTICS: * No prior prescribed low-residue diet for a clear medical reason * No established wheat intolerance or celiac disease * No concurrent condition precluding oral nutritional intake PRIOR CONCURRENT THERAPY: * No gastrointestinal stent * No jejunostomy, ileostomy, or colostomy * No concurrent participation in a study with toxicity as an endpoint

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

MeSH Terms

Conditions

Anus NeoplasmsUrinary Bladder NeoplasmsUterine Cervical NeoplasmsColorectal NeoplasmsFallopian Tube NeoplasmsOvarian NeoplasmsRadiation InjuriesSarcomaCarcinoma, Ovarian EpithelialColonic NeoplasmsRectal Neoplasms

Interventions

Diet TherapySerotonin Plasma Membrane Transport Proteins

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesColonic DiseasesFallopian Tube DiseasesAdnexal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersWounds and InjuriesNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeCarcinomaNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Nutrition TherapyTherapeuticsSymportersIon PumpsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsPlasma Membrane Neurotransmitter Transport ProteinsNeurotransmitter Transport ProteinsSolute Carrier ProteinsMembrane Proteins

Study Officials

  • Peter R. Blake, MD

    Royal Marsden NHS Foundation Trust

    STUDY CHAIR

  • Jervoise Andreyev, MD

    Royal Marsden NHS Foundation Trust

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2010

First Posted

July 27, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2012

Study Completion

January 1, 2014

Last Updated

November 1, 2016

Record last verified: 2010-07

Locations

GB(1)