Efficacy of Adding Hyperbaric Oxygen Therapy to the Treatment of Late Radiation Damage of the Lower Jaw (Osteoradionecrosis).
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- absence of exposed bone, fistulae or ulceration.
研究概览
简要总结
The purpose of this study is to determine whether hyperbaric oxygen therapy is effective in the treatment of osteoradionecrosis (late complication of radiation therapy) of the jaw.
详细描述
Damage to the lower jaw as a late complication of radiation therapy (osteoradionecrosis (ORN)) is often seen in patients treated with radiation therapy for a tumor in the head and neck region. Part of the lower jaw becomes non-vital and has to be treated. ORN proofs to be a condition difficult to treat and the treatment for this condition varies.
In many countries hyperbaric oxygen therapy (HBOT) is added to the surgical treatment of ORN. Unfortunately there is no consensus whether the addition of hyperbaric oxygen therapy to the treatment of ORN is beneficial or not. This study has the aim to investigate the efficacy and cost-effectiveness of HBOT in the treatment of ORN.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age ≥ 18 jr
- •WHO performance status 0-2
- •Last radiation treatment ≥ 6 month ago radiotherapy with curative intention and > 55 Gy. The affected part of the jaw must be in the target volume area of the radiotherapy field.
- •Local recurrence must be ruled out
- •Necrosis of the jaw with at least one of the following symptoms for over 3 month present:
- •Bone exposition which measures at least 1 cm
- •Evident bone lesions at radiologic evaluation (panorex) that fits the diagnosis ORN.
- •Non-healing extraction socket
排除标准
- •Former HBO treatment
- •Contra indication for HBO treatment (pneumothorax)
- •Bisphosphonate treatment in the medical history
- •reirradiation in the medical history
- •Osteosynthesis material in the affected area
- •Distant metastasis
- •Primary or recurrent tumor in the affected area
- •Malignancies elsewhere
研究组 & 干预措施
Hyperbaric oxygen therapy with surgery
Intervention arm. Hyperbaric oxygen therapy with surgery.
干预措施: hyperbaric oxygen (Drug)
结局指标
主要结局
absence of exposed bone, fistulae or ulceration.
时间窗: 12 months after finishing therapy in the arm assigned to
Number of patients with complete healing
次要结局
- Pain score(one year after therapy in the arm assigned to.)
- Clinical and radiological assessment of the treatment response(one year after therapy in the arm assigned to.)
- Completion of the therapy in the arm for which patient has been randomized; if someone drops out of this study the reason will be scored.(one year after therapy in the arm assigned to.)
- Use of pain medication(one year after therapy in the arm assigned to.)
- Type of surgical intervention(one year after therapy in the arm assigned to.)
- Quality of life(one year after therapy in the arm assigned to.)
- Cost effectiveness(one year after therapy in the arm assigned to.)