Head-and-neck Cancer
Conditions
Keywords
Gandoerma Spores Powder Capsules, head-and-neck cancer.
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.
Interventions
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.
In experimental group, Ganoderma Spores Powder Capsules for 12 weeks.
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients with head-and-neck cancer after complete treatment for at least 3 months (including surgery and/or radiotherapy and/or chemotherapy)
Exclusion criteria
* Patients with head-and-neck cancer under treatment or within 3 months after treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan