The Impact of Pentoxifylline and Vitamin E on The Incidence and Severity of Radiotherapy- Induced Oral Mucositis and Dysphagia in Patients With Head and Neck Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence and severity of radiotherapy-induced toxicity
研究概览
简要总结
The purpose of this study is to determine whether pentoxifylline and vitamin E are effective in prevention of radiotherapy- induced toxicity in head and neck cancer patients treated with concurrent chemoradiotherapy.
详细描述
This is a randomized controlled prospective study of pentoxifylline and vitamin E given on daily basis throughout the period of concurrent chemoradiotherapy to patients with carcinoma of the head and neck. All patients will be followed up to 90 days since the first day of treatment. The incidence and severity of adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adult patients
- •Measurable disease
- •Patients with squamous cell carcinoma of the head and neck eligible for treatment with concurrent chemo- radiotherapy
- •Able to understand and willing to sign a written informed consent document
排除标准
- •Pregnant or lactating women, since imaging cannot be done in this setting.
- •Patients treated with vitamin E and/ or pentoxifylline for any other indication
- •Patients with recent cerebral and/or retinal hemorrhage
- •Patients who have previously exhibited intolerance to pentoxifylline or methylxanthines such as caffeine, theophylline, and theobromine.
- •Patients treated with oral anticoagulants.
- •Absolute neutrophil count ≤1.5×109/L
- •Platelets ≤100×109/L
- •AST ≥ 2.5 X institutional upper limit normal (ULN)
- •Serum creatinine ≥ 1.5 mg% for males & 1.4 mg% for females
- •Serum bilirubin ≥ 1.5X institutional upper limit normal (ULN)
研究组 & 干预措施
Intervention Group
Platinum based concurrent chemoradiotherapy [cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks] .
Pentoxifylline 400 mg oral tablets twice daily for 7 weeks. Vitamin E 1000 mg oral capsules once daily for 7 weeks.
干预措施: Pentoxifylline (Drug)
Intervention Group
Platinum based concurrent chemoradiotherapy [cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks] .
Pentoxifylline 400 mg oral tablets twice daily for 7 weeks. Vitamin E 1000 mg oral capsules once daily for 7 weeks.
干预措施: Vitamin E (Drug)
Intervention Group
Platinum based concurrent chemoradiotherapy [cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks] .
Pentoxifylline 400 mg oral tablets twice daily for 7 weeks. Vitamin E 1000 mg oral capsules once daily for 7 weeks.
干预措施: Cisplatin (Drug)
Intervention Group
Platinum based concurrent chemoradiotherapy [cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks] .
Pentoxifylline 400 mg oral tablets twice daily for 7 weeks. Vitamin E 1000 mg oral capsules once daily for 7 weeks.
干预措施: Radiation therapy (Radiation)
Control Group
Platinum based concurrent chemoradiotherapy [cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks] .
干预措施: Cisplatin (Drug)
Control Group
Platinum based concurrent chemoradiotherapy [cisplatin (100mg/m2) on day 1, 22 and 43 of Radiotherapy (at 2 Gy/ fraction to a dose of 70 Gy over 7 weeks] .
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Incidence and severity of radiotherapy-induced toxicity
时间窗: 90 days since start of treatment
weekly follow-up for recording radiotherapy-induced toxicity occurrence.weekly reported toxicities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
次要结局
- Patients' response to concurrent chemo-radiotherapy (objective response rate)(63 days since start of treatment)
- Duration of grade 3 or 4 radiotherapy-induced toxicity(90 days since start of treatment)
- Number of patients with unplanned breaks in radiotherapy(49 days since start of treatment)
- Functional oral intake score(90 days since start of treatment)
- incidence and grade of pentoxifylline and vitamin E- related adverse events (National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03)(90 days since start of treatment)
- Total dose of opioid analgesics required(90 days since start of treatment)
- Patients' quality of life assessed using the validated Arabic version of the EuroQol-5D-3L questionnaire(90 days since start of treatment)
研究者
Rana Sayed Fouad
Assistant Lecturer- Clinical Pharmacy Department
Ain Shams University