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临床试验/NCT02282839
NCT02282839Unknown3 期

The Influence of Glutamine on the Side Effects of Chemo-radiation in Head and Neck Cancer Patients - A Randomized Controlled Trial

Taichung Veterans General Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年1月最近更新:
适应症
干预措施

试验速览

阶段
3 期
入组人数
60
试验地点
2
主要终点
Oral mucositis

研究概览

简要总结

This study will enroll 60 consecutive patients who are scheduled to receive radiotherapy with/without chemotherapy due to head and neck cancers. Basic data will be recorded along with tumor related variables. Then they will be divided randomly into study group and control group. The study group will receive oral glutamine during radiotherapy while the control group will receive placebo during radiotherapy. The severity of oral mucositis (WHO grading system), pain status (visual analogue scale), quality of life questionnaires will also be documented. The differences between the two groups will be analyzed.

详细描述

Chemotherapy and radiotherapy are important therapeutic modalities for head and neck cancer patients. Oral mucositis is a common comorbidity during chemotherapy and radiotherapy. It was reported that 30-60% of patients underwent chemotherapy and over 90% of patients receiving radiotherapy had oral mucositis. Oral mucositis not only reduces the quality of life of cancer patients during therapy but also causes dysphagia and poor nutritional status. Severe oral mucositis may necessitate unplanned gaps between treatment which can undermine the chance of local control.

In terms of management of oral mucositis, maintaining of oral hygiene and avoid infection are essential manner. Topical agents such as sucralfate, benzydamine, antifungal drugs, vitamin E and treatment using laser were studied in the management of oral mucositis. Previous studies indicated the glutamine significantly reduced the incidence and severity of oral mucositis in patients underwent chemotherapy and bone marrow transplantation. However, few studies discussed the effect of glutamine on the impact of oral mucositis in head and neck cancer patients receiving radiotherapy with/without chemotherapy.

This study will enroll 60 consecutive patients who are scheduled to receive radiotherapy with/without chemotherapy due to head and neck cancers. Basic data will be recorded along with tumor related variables. Then they will be divided randomly into study group and control group. The study group will receive oral glutamine while the control group will receive placebo during radiotherapy. The severity of oral mucositis (WHO grading system, every week), pain status (visual analogue scale, every week), quality of life questionnaires (before, during and after radiotherapy) will also be documented. The differences between the two groups will be analyzed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Head and neck cancer patients scheduled to receive radiotherapy with or without chemotherapy

排除标准

  • Prior radiotherapy to the head and neck region
  • Severe liver or renal disease
  • Reye's syndrome
  • Allergy to glutamine
  • Reluctant to join the study

研究组 & 干预措施

Control group

Placebo Comparator

Placebo (Same ingredients without glutamine) one week before radiotherapy till the end of radiotherapy

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Oral mucositis

时间窗: 8 weeks

According to WHO grading system

次要结局

  • Quality of life(8 weeks)
  • Pain status(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shih-An Liu

Attending Physician

Taichung Veterans General Hospital

研究点 (2)

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