NCT01087268

Brief Summary

RATIONALE: Radiation therapy can cause long-term adverse effects. Hyperbaric oxygen therapy may be effective in lessening gastrointestinal symptoms caused by radiation therapy given for pelvic cancer. It is not yet known whether high-pressure oxygen is effective in treating adverse effects caused by radiation therapy. PURPOSE: This randomized phase III trial is studying hyperbaric oxygen therapy to see how well it works in treating long-term gastrointestinal adverse effects caused by radiation therapy in patients with pelvic cancer.

Trial Health

55
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Trial Health Score

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

Enrollment
75

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

July 15, 2011

Status Verified

March 1, 2010

Enrollment Period

2.9 years

First QC Date

March 13, 2010

Last Update Submit

July 14, 2011

Conditions

Bladder CancerCervical CancerColorectal CancerEndometrial CancerGastrointestinal ComplicationsLong-term Effects Secondary to Cancer Therapy in AdultsOvarian CancerProstate CancerRadiation ToxicitySarcomaTesticular Germ Cell TumorVaginal Cancer

Keywords

gastrointestinal complicationsradiation toxicitylong-term effects secondary to cancer therapy in adultsstage I rectal cancerstage II rectal cancerstage III rectal cancerstage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancerstage I bladder cancerstage II bladder cancerstage III bladder cancerstage IV bladder cancerstage IA cervical cancerstage IB cervical cancerstage IIA cervical cancerstage IIB cervical cancerstage III cervical cancerstage I vaginal cancerstage II vaginal cancerstage III vaginal cancerstage I malignant testicular germ cell tumorstage II malignant testicular germ cell tumorstage III malignant testicular germ cell tumorstage I endometrial carcinomastage II endometrial carcinomastage III endometrial carcinomastage I uterine sarcomastage II uterine sarcomastage III uterine sarcomastage IA ovarian epithelial cancerstage IB ovarian epithelial cancerstage IC ovarian epithelial cancerstage IIA ovarian epithelial cancerstage IIB ovarian epithelial cancerstage IIC ovarian epithelial cancerstage IIIA ovarian epithelial cancerstage IIIB ovarian epithelial cancerstage IIIC ovarian epithelial cancerstage IA ovarian germ cell tumorstage IB ovarian germ cell tumorstage IC ovarian germ cell tumorstage IIA ovarian germ cell tumorstage IIB ovarian germ cell tumorstage IIC ovarian germ cell tumorstage IIIA ovarian germ cell tumorstage IIIB ovarian germ cell tumorstage IIIC ovarian germ cell tumor

Outcome Measures

Primary Outcomes (1)

  • Gastrointestinal symptoms score using the IBDQ quality-of-life questionnaire

Secondary Outcomes (5)

  • Physician assessment of adverse effects using LENT SOMA scales of radiation injury

  • Patient self-assessments using EORTC QLQ-C30 and Defecation Problem Subscale of QLQ-CR38

  • Photographic images of rectal mucosa

  • Physician assessment of rectal dysfunction based on the modified CTCAE grading system

  • Health economics data

Interventions

questionnaire administrationOTHER
gastrointestinal complications management/preventionPROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Past history of rectal, prostate, testicular, bladder, uterine cervix, uterine corpus, vaginal, or ovarian cancer * Malignant disease (T1-3, N0-1, M0) * No evidence of cancer recurrence * Gastrointestinal symptoms attributable to prior radiotherapy received at least 1 year ago, meeting 1 of the following criteria: * Grade 2 or higher in any Late Effects in Normal Tissues Subjective, Objective, Management, and Analytic Scales (LENT SOMA) category * Grade 1 with difficult intermittent symptoms * Symptoms are not relieved by appropriate life-style advice and medication over a 3-month period PATIENT CHARACTERISTICS: * Must be physically and psychologically fit to undergo hyperbaric oxygen therapy * No claustrophobia * No epilepsy * No chronic obstructive airway disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, or untreated pneumothorax * No previous middle/inner ear operations (except grommets and similar procedures) and/or inability to equalize middle ear pressure * No contraindication or other inability to undergo magnetic resonance imaging, if required to rule out malignancy PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior surgery for rectal cancer * No prior hyperbaric oxygen therapy (excluding treatment for decompression illness) * No prior treatment with bleomycin

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 - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Urinary Bladder NeoplasmsUterine Cervical NeoplasmsColorectal NeoplasmsEndometrial NeoplasmsOvarian NeoplasmsProstatic NeoplasmsRadiation InjuriesSarcomaTesticular Germ Cell TumorVaginal NeoplasmsRectal NeoplasmsTesticular NeoplasmsCarcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleGenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesWounds and InjuriesNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeVaginal DiseasesTesticular DiseasesCarcinomaNeoplasms, Glandular and Epithelial

Study Officials

  • John R. Yarnold, MD, FRCR

    Royal Marsden NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 13, 2010

First Posted

March 16, 2010

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Last Updated

July 15, 2011

Record last verified: 2010-03

Locations

GB(1)