The Effect of Ganoderma on Patients With Head-and-neck Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effect of Gandoerma Spores Powder Capsules on the Post-treatment Life Quality and Immune Modulation of the Patients With Head-and-neck Cancer

Conditions
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Head-and-neck Cancer

Intervention / Treatment
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* Other: Control group
* Dietary Supplement: Ganoderma Spores Powder Capsules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo/Ganoderma<br>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. | Other: Control group<br>* 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.<br>Dietary Supplement: Ganoderma Spores Powder Capsules<br>* In experimental group, Ganoderma Spores Powder Capsules for 12 weeks.<br>|
| Experimental: Ganoderma<br>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. | Dietary Supplement: Ganoderma Spores Powder Capsules<br>* In experimental group, Ganoderma Spores Powder Capsules for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gandoerma Spores Powder Capsules, head-and-neck cancer.