Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial (RICH-ART)

Göteborg University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cystitis, Radio Induced

Treatments: Drug: Hyperbaric Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT01659723

2012-001381-15 (EudraCT Number)

RICH-ART 2012-001381-15

Details and patient eligibility

About

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)

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 2 patient groups

A - Immediate start

Active Comparator group

Description:

Start of treatment within 6 weeks of inclusion in the study. 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.

Treatment:

Drug: Hyperbaric Oxygen

B - delayed start

No Intervention group

Description:

Delayed start: Start of treatment not before 6 months of inclusion in the study. No intervention is given during the initial period.