The Effect of Ganoderma on Patients With Head-and-neck Cancer
- Conditions
- Head-and-neck Cancer
- Interventions
- Other: Control groupDietary Supplement: Ganoderma Spores Powder Capsules
- Registration Number
- NCT02238587
- Lead Sponsor
- Chang Bing Show Chwan Memorial Hospital
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Patients with head-and-neck cancer after complete treatment for at least 3 months (including surgery and/or radiotherapy and/or chemotherapy)
- Patients with head-and-neck cancer under treatment or within 3 months after treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo/Ganoderma Control group 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. Ganoderma Ganoderma Spores Powder Capsules 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. Placebo/Ganoderma Ganoderma Spores Powder Capsules 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.
- Primary Outcome Measures
Name Time Method Immune modulation such as tumor necrosis factors-α or interleukin-6 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.
- Secondary Outcome Measures
Name Time Method Life quality Change from baseline in life quality at 6 months Health and life quality will assessed by Quality of Life Questionnaire at three different times: (1)baseline data: before intervention, (2)outcome data: at 6 and 12 weeks post-oral intervention.
Trial Locations
- Locations (1)
Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital
🇨🇳Changhua County, Taiwan