IRCT2015091015860N3已完成2 期
Efficacy of the Malva sylvestris & Alcea digitata compound on prevention of radiation induced xerostomia in head and neck cancer patients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 17 years 至 65 years(—)
- 性别
- All
入选标准
- •Inclusion criteria include:
- •1. head and neck cancer patients who candidate for radiation therapy
- •2. minimum age of 17 and maximum age of 65 years old
- •3. having Good Performance status according with ECOG questionnaire criteria
- •4. having at least 4 regions of mucositis (based on a measure of mucositis) in the field of radiation therapy
- •5. physically and mentally able to fill out a questionnaire
- •6. willingness to participate in the study
- •7. survival more than one year according to the oncologist or treatment team.
- •Exclusion criteria:The use of alcohol, medicines which affecting the salivary glands such as: anti-depression, opioids, anti-hypertensive, antihistamines, diuretics, types of mouthwash and artificial saliva and smoking during the study; Receiving radiation therapy and chemotherapy in the mouth and oropharynx in the six months ago; The history of connective tissue diseases such as Sjogren's syndrome, rheumatoid arthritis, lupus, liver and kidney disease, major depression, diseases involving salivary glands, diabetes, chronic diseases such as diarrhea cause dehydration, immune suppression disorders, myelosuppression, disorders which causing frequent aphthous stomatitis; Sudden changes in the patient's condition or disease in which changing the predicted radiation procedure for patient before getting to dose of 50 Gy; Grade 3 & 4 mucositis; Candidiasis and oral herpes infection; Failure/ need parenteral nutrition (TPN) or hospitalization; Unwillingness to continue participation in the study
排除标准
- 未提供
研究者
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