The Effect of Gandoerma Spores Powder Capsules on the Post-treatment Life Quality and Immune Modulation of the Patients With Head-and-neck Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Immune modulation such as tumor necrosis factors-α or interleukin-6
研究概览
简要总结
To study the effect of Ganoderma Spores Powder Capsules on the life quality and immunity status of the patients with head-and-neck cancer after complete treatment (including surgery and / or radiotherapy and/or chemotherapy)
详细描述
Ganoderma is known to modulate immunity and improve health. However, the mechanism is not clear. We hypothesize that patients who have completed standard treatment with/without radiotherapy might require biological modifier such as Ganoderma to improve life quality and immunity status.
A total of 100 patients are randomized to study and control groups. In study group, Ganoderma Spores Powder Capsules are given to the patients for 6 weeks, In control group, only placebos are given during the same period. Then the patients in study and control groups are switched, Ganoderma Spores Powder Capsules and placebos are given for 6 weeks. The data pertaining to their Life quality are collected using Quality of Life Questionnaire after the first 6 weeks and the second 6 weeks. The immunity status is also studied at the same time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with head-and-neck cancer after complete treatment for at least 3 months (including surgery and/or radiotherapy and/or chemotherapy)
排除标准
- •Patients with head-and-neck cancer under treatment or within 3 months after treatment
结局指标
主要结局
Immune modulation such as tumor necrosis factors-α or interleukin-6
时间窗: Change from baseline in cytokines at 6 months
Subjects will be assigned to receive placebo/Ganoderma or Ganoderma Spores Powder Capsules twice a day for 12 weeks. Peripheral blood and saliva will be collected at 3 different times: (1)baseline data: before oral intervention, (2)outcome data: at 6 and 12 weeks post-oral intervention.
次要结局
- Life quality(Change from baseline in life quality at 6 months)
研究者
Kuender D. Yang
MD, PhD, Professor
Chang Bing Show Chwan Memorial Hospital