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
研究组 & 干预措施
Placebo/Ganoderma
In control group, oral placebos for 6 weeks. Then the patients in control groups are switched, Ganoderma Spores Powder Capsules 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.
干预措施: Control group (Other)
Placebo/Ganoderma
In control group, oral placebos for 6 weeks. Then the patients in control groups are switched, Ganoderma Spores Powder Capsules 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.
干预措施: Ganoderma Spores Powder Capsules (Dietary Supplement)
Ganoderma
In experimental group, Ganoderma Spores Powder Capsules for 12 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.
干预措施: Ganoderma Spores Powder Capsules (Dietary Supplement)
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