Radiation Induced Cystits treated with Hyperbaric Oxygen. A Randomized controlled Trial

Conditions: Radiation Cystitis
MedDRA version: 14.1Level: PTClassification code 10057480Term: Hyperbaric oxygen therapySystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2012-001381-15-SE

Lead Sponsor: Sahlgrenska University Hospital Västra Götalandsregionen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 80

Inclusion Criteria

-Provision of informed consent prior to any study specific procedures
- Female or male aged 18-80 years
- Intended curative radiation of the pelvic region as a treatment for cancer
- End of radiation therapy more than 6 months ago
- Radiation cystitis with Urological EPIC < 80
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Patients with major and ongoing bleedings from the bladder (requiring more than 0.5L blood-transfusion within the last four weeks)
- Refractory incontinence requiring catheter or surgical intervention
- Urine bladder capacity < 100ml
- Fistula in the urine bladder
- Contraindications for HBO therapy according to the local centres routines
- Pregnancy
- Mechanical ventilator support
- Unable to follow and understand simple commands
- Not oriented to person, place and time

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the relief of symptoms after HBO therapy in patients with late radiation cystitis by having EPIC symptom estimation scale as primary variable;Secondary Objective: •To investigate the mucosa with respect to functionality by assessment of inflammation activity, quantification of fibrosis, vascular density and the presence of stems cells having histological analysis from biopsies as variable<br>•To assess the severity of radiation injury having the RTOG-scale as variable <br>•To assess health-related quality of life before and after HBO therapy having SF-36 as the variable<br>;Primary end point(s): The primary endoint is symptom rating after HBO therapy using the self-administrated EPIC-questionnaire original score as the primary variable;Timepoint(s) of evaluation of this end point: At baseline and at Visit 4, 6-8 weeks after finalized treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Severity of radiation injury having the RTOG as the variable at baseline and visit 4<br>•Histological analysis of inflammation activity, degree of fibrosis, vascular density and the presence of stems cells at baseline and visit 4. <br>•Health-related quality of life (SF36) at baseline visit 3, 4 and 5<br>•Post-study long-term follow-up follow up with Symptom rating (EPIC) and Health-related quality of life (SF36);Timepoint(s) of evaluation of this end point: Baseline (visit 1) and 6-8 months (visit 4).<br>SF-36 also immediately after finalized HBOT (visit 3 and 5)<br>Long-term follow-up: 5 years after finalized study