A Pilot Study of Additional Chinese Formula for Concurrent Chemoradiotherapy in Oral Cavity Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- The completion rate
研究概览
简要总结
The goal of this clinical trial is to learn about the clinical efficacy of San-Zhong-Kui-Jian-Tang (SZKJT), a formula of Chinese medicine in head and neck cancer patients receiving concurrent chemoradiotherapy (CCRT) treatments. The main questions it aims to answer are:
- Can SZKJT improve the completion rate of CCRT?
- Can SZKJT reduce the adverse effects of CCRT?
- How SZKJT affect the quality of life in the patients receiving CCRT
- How about the safety of using SZKJT in the patients receiving CCRT
Participants will be asked to:
- take SZKJT for 9 weeks during the whole CCRT course
- take questionnaires of quality of life
详细描述
San-Zhong-Kui-Jian-Tang (SZKJT) is originated from the Secret Treasure of the Orchid Chamber written by Gao Li (AC1180 - 1251). SZKJT contains 16 herbs to treat abnormal swelling or nodules. In the theory of Chinese medicine, SZKJT can clear heat and resolve toxin, which leads to disperse swelling and binds in nodules.
The purpose of this study is to explore the clinical efficacy and safety of SZKJT in improving the completion rate of concurrent chemoradiotherapy (CCRT) in patients with head and neck cancer, and to evaluate the prevention and treatment effects of SZKJT on the side effects of chemoradiotherapy, as well as the improvement of quality of life.
The primary endpoint of the study is the completion rate of CCRT under SZKJT treatment. The secondary endpoints are adverse effects of CTCAE, body constitution questionnaire (BCQ) and the EORTC core quality of life questionnaire (QLQ-C30). Liver and kidney functions are considered as well for adverse effects of SZKJT. We hypothesized that additional SZKJT with CCRT might improve completion rate of CCRT and reduce severity of adverse effects of CCRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged from 20- to 65-year-old;
- •firstly diagnosed as head and neck cancer with stage II, III or IV;
- •adjuvant therapy with chemotherapy of Cisplatin or combined with radiotherapy after surgery;
- •or chemotherapy of Cisplatin for those without surgery;
- •wiliness to sign inform consent.
排除标准
- •pregnancy;
- •non-Squamous-cell carcinoma;
- •secondary cancer or Carcinoma in situ in 5 years;
- •any evidence of metastasis;
- •abnormality of liver, kidney or bone marrow functions before treatments;
- •unstable vital signs;
- •episode of acute infection;
- •unclear consciousness for inform consent;
- •receiving other herbal, complementary or acupuncture therapy.
研究组 & 干预措施
SZKJT group
Patients who meet the inclusion criteria and agree to receive concomitant treatment with SZKJT.
干预措施: SZKJT(San-Zhong-Kui-Jian-Tang) (Drug)
结局指标
主要结局
The completion rate
时间窗: We will do an assessment at the seventh week of CCRT. Patients who had completed a seven-week course of treatment and had a cumulative dose of cisplatin greater than 200 mg per m2 will be considered the completion group.
We counted the percentage rate of those who achieved and did not reach the CCRT course.
次要结局
- The adverse effects(The assessment is performed at the eighth week.)
- The change in Quality of Life(The questionnaire is assessed at the baseline and the eighth week.)
- The change of renal function(The lab data of biochemistry analysis is collected at the baseline and the eighth week.)
- The Change of Constitutions of traditional Chinese medicine(The questionnaire is assessed at the baseline and the eighth week.)
- The change of liver function(The lab data of biochemistry analysis is collected at the baseline and the eighth week.)