Treatment of Radiation-induced Fibrosis in the Upper Aerodigestive Tract Cancer by a Combination of Pentoxifylline-tocopherol and Hyperbaric Oxygen
试验速览
- 阶段
- 2 期
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in skin fibrosis measured by MRI
研究概览
简要总结
The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of the fibrosis.
Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical conditions including the treatment of delayed radiation injuries (soft tissue and bony radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation tissue and produces angiogenesis maintained after use.
详细描述
Patients with head and neck tumors often present superficial radiation induced fibrosis and other late complications of radiotherapy that can seriously affect their quality of life.
The pentoxifylline used with tocopherol achieves a certain effectiveness in the treatment of the fibrosis.
Hyperbaric oxygen therapy has been recommended and used in a wide variety of medical conditions including the treatment of delayed radiation injuries (soft tissue and bony radiation necrosis). The hyperbaric oxygen therapy increases the formation of granulation tissue and produces angiogenesis maintained after use.
Both treatments in combination could produce a synergistic effect because the angiogenesis induced by hyperbaric oxygen therapy allow better access to drugs to the injury. The magnetic resonance, provides data of the fibrosis and other side effects of radiotherapy.
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
- •Over 18 years and under 70 years old.
- •Patients who have received radiotherapy after being diagnosed with cancer of upper aerodigestive tract, and have skin toxicity grade II or higher.
- •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.
- •Patients with metal objects or electronic devices such as cardiac pacemakers, artificial heart valves or cochlear implants, or any other contraindication for MRI
- •Contraindication for Hyperbaric oxygen therapy.
- •Patients with mobility problems.
- •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 + Tocopherol
Pentoxifylline 800 mg/day (400 mg/12hours) + Tocopherol 1000 mg/day oral during 6 months
干预措施: pentoxifylline with tocopherol (Drug)
pentoxifylline + tocopherol + Hyperbaric Oxygen Therapy
干预措施: pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy (Other)
结局指标
主要结局
Change in skin fibrosis measured by MRI
时间窗: From baseline to 6 month of starting treatment
The change is calculated as the latest time point (6 months) minus the earliest time point (baseline)
次要结局
- Clinical assessment of the radiation late (delayed) toxicity for mucosal membranes, salivary glands, larynx and skin by the LENT-SOMA scale (Late Effect Normal Tissue Task Force / Subjective, Objective, Management, Analytic scale)(Baseline and 6 months)