Advances in the Management of Mandibular Osteoradionecrosis: Pentoxifylline and Tocopherol as Medical Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).
研究概览
简要总结
Mandibular osteoradionecrosis, despite its low incidence, remains being the most problematic and irreversible complication after head and neck radiotherapy with no medical treatment to limit or reduce symptoms.
Different clinical trials have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis. This study proposes to use this drugs to determine if there is healing of mandibular osteoradionecrosis and/or a symptomatic improvement as well.
详细描述
Mandibular osteoradionecrosis which occurs after the use of radiation therapy for the treatment of head and neck cancer remains being the most problematic and irreversible complication despite its low incidence with no medical treatment to limit or reduce symptoms.
Clinical trials conducted to date have shown a significant scientific evidence that the treatment with pentoxifylline + tocopherol achieves a certain effectiveness in the treatment of the tissue fibrosis that have been irradiated based on the properties of this drugs in increased tissue oxygenation and their antioxidant effect.
The aim of this study is to determine if there is a clinical improvement of mandibular osteoradionecrosis using Pentoxifylline in combination with Tocopherol as treatment because, currently, there is no effective treatment to achieve bone healing and/or a symptomatic improvement.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years and under 90 years old.
- •Patients who have received radiotherapy after being diagnosed with head and neck cancer and currently are diagnosticated of mandibular osteoradionecrosis (any clinical stage)
- •Follow-up for at least a year after the radiation treatment is completed.
- •Absence of tumor at the time of recruitment.
- •Patients with the capacity to give informed consent
排除标准
- •Allergy or hypersensitivity to Pentoxifylline or others xanthines, or to Tocopherol (vitamin E).
- •Patients taking oral anticoagulants (acenocoumarol, warfarin).
- •Known hemorrhagic/coagulation disorder.
- •Vitamin K deficiency due to any cause.
- •Use of estrogens oral contraceptives.
- •Serious bleeding or extensive retinal hemorrhage.
- •Ischaemic heart diseases, including recent Myocardial Infarction.
- •Serious cardiac arrhythmia.
- •Severe LIVER DISEASE.
- •Severe renal failure (creatinine clearance <30 mL/min).
- •Hypotension.
- •Female patients who are pregnant or lactating
- •Any other situation or condition that, in the opinion of the INVESTIGATOR, may interfere with optimal PARTICIPATION in the study.
研究组 & 干预措施
Pentoxifylline and Tocopherol
Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.
干预措施: Pentoxifylline and Tocopherol (Drug)
结局指标
主要结局
Bone and/or Tissue Healing as Measured With the Classification of ORN Stages, Area of Bone Exposed (mm2) and Radiological Findings (OPG).
时间窗: From baseline to 1, 3, 6, and 9 months of starting treatment
Clinical healing assessment as measured with the classification of ORN stages, area of bone exposed (mm2) and radiological findings (OPG). Intraoral bone exposure is measured in mm2.
次要结局
- Clinical Symptoms Evaluation, Measured Using the LENT-SOMA Scale(From baseline to 1,3, 6, 9 months of starting treatment)
研究者
Miriam Martos-Fernandez
Oral and Maxillofacial Surgeon
Hospital Vall d'Hebron