Clinical trial NCT01659723: Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial
Official title: Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cystitis, Radio Induced
Keywords: Radio therapy
STRI
Urinary bladder
Hyperbaric Oxygen
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
First posted: 2012-08-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed description: Radiotherapy is commonly used in the management of malignant diseases. Despite a continuous improvement of the technique, with improved efficacy and tolerance, adverse effects are still rather common. The urinary bladder and rectum are the major organs most commonly affected by radiotherapy to the pelvis area.

One of the most significant causes of the symptoms of radio therapy is inflammation and degeneration of blood vessels in the radiated tissue. Hyperbaric oxygen therapy involves administration of oxygen at greater than normal atmospheric pressures. A well-documented effect of HBOT is the stimulation of angiogenesis. HBOT is an established treatment for degeneration of blood vessels in the jaw bone as a result of radiotherapy and several publications have shown good efficacy also when soft tissue is affected.

If the method of treatment with HBOT means a reduction of the radiotherapy side effect it is thus an obvious importance for the individual patient. There is also significant potential savings for the healthcare and society.

Eligibility 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

Primary outcomes:
measure: EPIC (Expanded Prostate cancer Index Composite)
timeFrame: At inclusion, 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B) and for long-term follow-up as specified under "description"
Secondary outcomes:
measure: Microscopic assessment
timeFrame: At inclusion and 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B)
measure: RTOG (Radiation Toxicity Grade by Radiation Therapy Oncology Group)
timeFrame: At inclusion and 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B)
measure: SF-36 (Short Form Health Survey 36)
timeFrame: At inclusion, 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B) and for long-term follow-up as specified under "description"
measure: Adverse events
timeFrame: Every day during HBOT (8 weeks).
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet Copenhagen
city: Turku
country: Finland
facility: Turku Hospital
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Gothenburg
country: Sweden
facility: Shalgrenska University Hospial
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Sahlgrenska, Gothenburg University
name: Nicklas Oscarsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oscarsson N, Muller B, Rosen A, Lodding P, Molne J, Giglio D, Hjelle KM, Vaagbo G, Hyldegaard O, Vangedal M, Salling L, Kjellberg A, Lind F, Ettala O, Arola O, Seeman-Lodding H. Radiation-induced cystitis treated with hyperbaric oxygen therapy (RICH-ART): a randomised, controlled, phase 2-3 trial. Lancet Oncol. 2019 Nov;20(11):1602-1614. doi: 10.1016/S1470-2045(19)30494-2. Epub 2019 Sep 16.