Radiation Induced Cystitis Treated With Hyperbaric Oxygen - A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 5
- 主要终点
- EPIC (Expanded Prostate cancer Index Composite)
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
A - Immediate start
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.
干预措施: Hyperbaric Oxygen (Drug)
结局指标
主要结局
EPIC (Expanded Prostate cancer Index Composite)
时间窗: 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"
EPIC was developed to measure health-related quality of life among men with prostate cancer (22) modified to enhance sensitivity to therapy effects. It comprises four summary domains; urinary, bowel, sexual and hormonal. The primary objective of this study is to assess the relief of symptoms after HBOT in patients with late radiation cystitis by having EPIC symptom estimation scale as primary variable, comparing results between group A (post treatment) and group B (pre treatment). All patients (Group A and B) will complete EPIC and SF-36 in a post-study long-term follow-up. This is done yearly for 5 years (18, 30, 42, 54 and 66 months post inclusion).
次要结局
- RTOG (Radiation Toxicity Grade by Radiation Therapy Oncology Group)(At inclusion and 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B))
- Adverse events(Every day during HBOT (8 weeks).)
- Microscopic assessment(At inclusion and 6 months after inclusion (i.e. post treatment for group A and pre treatment for group B))
- SF-36 (Short Form Health Survey 36)(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")