MedTrace Logo

Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial

NCT01659723 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2019-06-26

No results posted yet for this study

Summary

The primary objective of this study is to assess the relief of symptoms after Hyperbaric Oxygen Therapy (HBOT) in patients with late radiation cystitis by having Expanded Prostate cancer Index Composite (EPIC)symptom estimation scale as primary variable.

Study hypothesis:

* HBOT can reduce or reverse the change or otherwise limit the damage of the bladder function and/or structure, which arose as a result of radiation therapy of cancer in the pelvic region organs.
* The effects of HBOT are associated with relief of symptoms that, at least in part, is related to the reduction of the extent of the radiation damage.
* Vascular density increases, fibrosis prevalence and inflammatory activity are reduced as a sign of an improved function of the mucosa.
* Treatment results of HBOT remains, in whole or in part, during the follow-up (residual effect)

Conditions

  • Cystitis, Radio Induced

Interventions

DRUG

Hyperbaric Oxygen

100% oxygen at 240-250 kPa will be delivered to the patents for 80-90 minutes while sitting or lying in a hyperbaric oxygen chamber. Patients will receive treatment once every day, except week-ends, for 40 days.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Göteborg University

    lead OTHER

Principal Investigators

  • Nicklas Oscarsson, MD · Sahlgrenska, Gothenburg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2018-08-09
Completion
2018-08-09

Countries

  • Denmark
  • Finland
  • Norway
  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01659723 on ClinicalTrials.gov