Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo/Ganoderma | Placebo Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control group | Other | In control group, only placebos are given for 6 weeks. The patients who are in control groups are switched to receive Ganoderma Spores Powder Capsules for 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Immune modulation such as tumor necrosis factors-α or interleukin-6 | 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. | Change from baseline in cytokines at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Life quality | 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. | Change from baseline in life quality at 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ching-Yeh Hsiung | Contact | 886-975617327 | hsiungcy@hotmail.com | |
| Kuender D. Yang | Contact | 886-975617006 | yangkd.yeh@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kuender D. Yang, PhD | Chang Bing Show Chwan Memorial Hospital | Study Director |
| Ching-Yeh Hsiung | Chang Bing Show Chwan Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital | Recruiting | Changhua County | Taiwan |
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ganoderma Spores Powder Capsules | Dietary Supplement | In experimental group, Ganoderma Spores Powder Capsules for 12 weeks. |
|
| D008722 | Methods |