<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02238587</url>
  </required_header>
  <id_info>
    <org_study_id>1020304</org_study_id>
    <nct_id>NCT02238587</nct_id>
  </id_info>
  <brief_title>The Effect of Ganoderma on Patients With Head-and-neck Cancer</brief_title>
  <official_title>The Effect of Gandoerma Spores Powder Capsules on the Post-treatment Life Quality and Immune Modulation of the Patients With Head-and-neck Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Bing Show Chwan Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Bing Show Chwan Memorial Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the effect of Ganoderma Spores Powder Capsules on the life quality and immunity&#xD;
      status of the patients with head-and-neck cancer after complete treatment (including surgery&#xD;
      and / or radiotherapy and/or chemotherapy)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ganoderma is known to modulate immunity and improve health. However, the mechanism is not&#xD;
      clear. We hypothesize that patients who have completed standard treatment with/without&#xD;
      radiotherapy might require biological modifier such as Ganoderma to improve life quality and&#xD;
      immunity status.&#xD;
&#xD;
      A total of 100 patients are randomized to study and control groups. In study group, Ganoderma&#xD;
      Spores Powder Capsules are given to the patients for 6 weeks, In control group, only placebos&#xD;
      are given during the same period. Then the patients in study and control groups are switched,&#xD;
      Ganoderma Spores Powder Capsules and placebos are given for 6 weeks. The data pertaining to&#xD;
      their Life quality are collected using Quality of Life Questionnaire after the first 6 weeks&#xD;
      and the second 6 weeks. The immunity status is also studied at the same time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">May 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immune modulation such as tumor necrosis factors-α or interleukin-6</measure>
    <time_frame>Change from baseline in cytokines at 6 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Life quality</measure>
    <time_frame>Change from baseline in life quality at 6 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Head-and-neck Cancer</condition>
  <arm_group>
    <arm_group_label>Placebo/Ganoderma</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ganoderma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>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.</description>
    <arm_group_label>Placebo/Ganoderma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Ganoderma Spores Powder Capsules</intervention_name>
    <description>In experimental group, Ganoderma Spores Powder Capsules for 12 weeks.</description>
    <arm_group_label>Ganoderma</arm_group_label>
    <arm_group_label>Placebo/Ganoderma</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with head-and-neck cancer after complete treatment for at least 3 months&#xD;
             (including surgery and/or radiotherapy and/or chemotherapy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with head-and-neck cancer under treatment or within 3 months after treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kuender D. Yang, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ching-Yeh Hsiung</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Bing Show Chwan Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ching-Yeh Hsiung</last_name>
    <phone>886-975617327</phone>
    <email>hsiungcy@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kuender D. Yang</last_name>
    <phone>886-975617006</phone>
    <email>yangkd.yeh@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Division of Core Laboratory; Chang Bing Show Chwan Memorial Hospital</name>
      <address>
        <city>Changhua County</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kuender D. Yang, PhD</last_name>
      <phone>886-975617006</phone>
      <email>yangkd.yeh@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 8, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 9, 2014</last_update_submitted>
  <last_update_submitted_qc>September 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Bing Show Chwan Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Kuender D. Yang</investigator_full_name>
    <investigator_title>MD, PhD, Professor</investigator_title>
  </responsible_party>
  <keyword>Gandoerma Spores Powder Capsules, head-and-neck cancer.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02238587
org study id: 1020304
nct id: NCT02238587
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Crossover Assignment
masking: Double (Participant, Outcomes Assessor)
measure: Immune modulation such as tumor necrosis factors-α or interleukin-6
time frame: Change from baseline in cytokines at 6 months
description: 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.
measure: Life quality
time frame: Change from baseline in life quality at 6 months
description: 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.
arm group label: Placebo/Ganoderma
arm group type: Placebo Comparator
description: 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.
arm group label: Ganoderma
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: Control group
description: 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.
arm group label: Placebo/Ganoderma
intervention type: Dietary Supplement
intervention name: Ganoderma Spores Powder Capsules
description: In experimental group, Ganoderma Spores Powder Capsules for 12 weeks.
arm group label: Ganoderma
arm group label: Placebo/Ganoderma
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Kuender D. Yang, PhD
role: Study Director
affiliation: Chang Bing Show Chwan Memorial Hospital
last name: Ching-Yeh Hsiung
role: Principal Investigator
affiliation: Chang Bing Show Chwan Memorial Hospital
last name: Ching-Yeh Hsiung
phone: 886-975617327
email: hsiungcy@hotmail.com
last name: Kuender D. Yang
phone: 886-975617006
email: yangkd.yeh@hotmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: Chang Bing Show Chwan Memorial Hospital
investigator full name: Kuender D. Yang
investigator title: MD, PhD, Professor
mesh term: Head and Neck Neoplasms