The Effect of Alpha Lipoic Acid on the Incidence and Severity of Radiotherapy-Induced Oral Mucositis in Head and Neck Cancer Patients
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence and severity of radiation induced oral mucositis
研究概览
简要总结
A prospective, randomized, controlled, single-blinded study will be conducted at Clinical Oncology department, Ain Shams University Hospitals, assessing the effect of Alpha Lipoic Acid on the incidence and severity of radiotherapy induced oral mucositis in Head and Neck cancer patients.
详细描述
All patients presenting to the Clinical Oncology department, Ain Shams University Hospitals, will be assessed for eligibility as follow:
Inclusion criteria:
- Age >18 years.
- Diagnosis of stage I, II, III or IV squamous cell carcinoma, nasopharyngeal carcinoma.
- Measurable disease on CT scan at baseline.
- Planned to receive radiotherapy with a total dose 60 grays or more divided on 30 fractions with or without cisplatin (100 mg/m2, administered intravenously every 21 days for three cycles or 40 mg/m2 administered weekly for up to 7 weeks).
- Adequate liver function (liver transaminases level < 3 times upper normal limits and total bilirubin < 1.5 times upper normal limits).
- Adequate kidney function (estimated glomerular filtration rate >60 ml/min).
- Adequate bone marrow function (WBCs count > 3000 cells/mm3, ANC count >1500 cells/mm3 and platelets count > 100,000 cells/mm3).
Exclusion criteria:
Patients will be excluded if they have any of the following:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Age >18 years.
- •Diagnosis of stage I, II, III or IV squamous cell carcinoma, nasopharyngeal carcinoma.
- •Measurable disease on CT scan at baseline.
- •Planned to receive radiotherapy with a total dose 60 grays or more divided on 30 fractions with or without cisplatin (100 mg/m2, administered intravenously every 21 days for three cycles or 40 mg/m2 administered weekly for up to 7 weeks).
- •Adequate liver function (liver transaminases level < 3 times upper normal limits and total bilirubin < 1.5 times upper normal limits).
- •Adequate kidney function (estimated glomerular filtration rate >60 ml/min).
- •Adequate bone marrow function (WBCs count > 3000 cells/mm3, ANC count >1500 cells/mm3 and platelets count > 100,000 cells/mm3).
排除标准
- •● Diagnosis of Thyroid cancer.
- •Presence of other primary cancers.
- •Treatment with alpha lipoic acid for any other indication.
- •Allergy to alpha lipoic acid.
- •Pregnant or lactating women.
研究组 & 干预措施
Alpha Lipoic Acid Group (intervention group)
35 patients will receive radiation therapy with or without platinum-based chemotherapy in addition to alpha lipoic acid 600 mg tablets twice daily (throughout the radiotherapy period). .
干预措施: Alpha Lipoic Acid 600 MG Oral Tablets (Drug)
Alpha Lipoic Acid Group (intervention group)
35 patients will receive radiation therapy with or without platinum-based chemotherapy in addition to alpha lipoic acid 600 mg tablets twice daily (throughout the radiotherapy period). .
干预措施: radiation or concurrent chemoradiation (Radiation)
Control Group
35 Patients will receive radiation therapy with or without platinum-based chemotherapy in addition to placebo tablets twice daily (throughout the radiotherapy period)
干预措施: Placebo tablets (Other)
Control Group
35 Patients will receive radiation therapy with or without platinum-based chemotherapy in addition to placebo tablets twice daily (throughout the radiotherapy period)
干预措施: radiation or concurrent chemoradiation (Radiation)
结局指标
主要结局
Incidence and severity of radiation induced oral mucositis
时间窗: 4 months
The patients will be followed up during the whole period of radiation and up to six weeks after radiation to evaluate the incidence and severity of radiation induced mucositis. Severity will be assessed by the oncologist using radiotherapy oncology group criteria (RTOG criteria)
次要结局
- Time to develop grade III or IV radiation induced oral mucositis:(4 months)
研究者
Bishoy Anwar
principal investigator
Ain Shams University