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

• Status: Completed
• Trial end date: 2018-08-09
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Göteborg University
• Collaborator: Sahlgrenska University Hospital, Sweden

Criteria

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

• Radiation cystitis is the most probable cause for the patient's symptoms

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 HBOT according to the local centres routines

• Pregnancy

• Mechanical ventilator support

• Unable to follow and understand simple commands

• Not oriented to person, place and time