<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/NCT03015077</url>
  </required_header>
  <id_info>
    <org_study_id>KMUHIRB-2014-12-01(II)</org_study_id>
    <nct_id>NCT03015077</nct_id>
  </id_info>
  <brief_title>Effects of Oral L-Glutamine in Head and Neck Cancer Patients During Radiotherapy</brief_title>
  <official_title>Impacts of Oral Supplement With L-Glutamine on the Radiation-induced Toxicity and Nutritional Status of Head and Neck Cancer Patients Under Radiotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaohsiung Medical University Chung-Ho Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaohsiung Medical University Chung-Ho Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The rapidly increasing mortality and incidence of oral cancer has become a public health&#xD;
      major problem in Taiwan. To date, the treatment of head and neck cancer mainly include&#xD;
      surgery, radiotherapy and chemotherapy. However, radiotherapy and chemotherapy might have an&#xD;
      influence on the patients' diet by causing dismal side effects, including nausea, vomiting,&#xD;
      pain, infection, dysorexia, allotriogeustia, oral ulceration and dysphagia, which make the&#xD;
      patients more difficult to absorb nutrients. In the previous study, the incidence of&#xD;
      malnutrition among the patients with cancer has been estimated at between 40 and 80%,&#xD;
      especially occurred in the patients with head and neck cancers and upper gastrointestinal&#xD;
      cancers.&#xD;
&#xD;
      In this study, the effect of supplement with L-Glutamine on the nutritional status and&#xD;
      radiation-induced toxicity of head and neck cancer patients will be evaluated to improve the&#xD;
      patients' quality of life when they are undergoing radiotherapy. When the head and neck&#xD;
      cancer patients undergoing radiotherapy, patients' instructions and nutrient intervention of&#xD;
      L-Glutamine are performed to maintain the patients' nutritional status and reduce the&#xD;
      patients' diet-related or other side effects caused by radiotherapy. It is anticipated that&#xD;
      head and neck cancer patients with surgery and radiotherapy intake with L-Glutamine might&#xD;
      decrease treatment-related side effects and hence improve their quality of life when they are&#xD;
      undergoing radiotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Written informed consent must be obtained before any study specific procedures are&#xD;
           undertaken.&#xD;
&#xD;
        2. The process of the experiment A. head and neck cancer patients with surgery and&#xD;
           radiotherapy are identified in clinic at the Department of Dentistry and the Department&#xD;
           of Radiotherapy in Kaohsiung Medical University Chung-Ho Memorial Hospital.&#xD;
&#xD;
      B. Inform these patients about the value of this clinical trial in detail, and make sure that&#xD;
      they understand all the meanings of each procedure in this clinical trial. Subsequently, the&#xD;
      patients who are willing to participate in this study are enrolled after completing&#xD;
      institutionally approved informed consent.&#xD;
&#xD;
      C. In order to assess the effect of supplement with L-Glutamine on the nutritional status and&#xD;
      diet of head and neck cancer patients with surgery and radiotherapy, the enrolled patients&#xD;
      will be divided into two groups randomly. One group is supplied with 10 g L-Glutamine and 5 g&#xD;
      maltodextrin; the other group is supplied with 15 g maltodextrin as control group. The&#xD;
      patients of these two groups take their supplemental nutrients three times a day,&#xD;
      respectively, in a period of time of 7 days before radiotherapy to 14 days after&#xD;
      radiotherapy.&#xD;
&#xD;
      D. Meanwhile, the research assistants will monitor the patients' condition carefully by&#xD;
      recording their daily diet, nutritional status and side effects caused by radiotherapy at&#xD;
      three specific time-points during the whole clinic trial program course.&#xD;
&#xD;
      E. The monitor items of patients' nutritional status include the daily diet of patients&#xD;
      before and after radiotherapy by recording 24 hr recall table and food frequency table,(b)&#xD;
      the physical examination of height, weight, ideal weight, tricept skinfold (TSF), mid-arm&#xD;
      circumference (MAC) and mid-arm muscle circumference (MAMC), (d) prognostic nutritional index&#xD;
      (PNI), (e) biochemistry inspection assessment and (g) complete blood count (CBC).&#xD;
&#xD;
      F. The monitor items of patients' diet-related side effects caused by radiotherapy include&#xD;
      (a) oral mucositis and (b) neck dermatitis.&#xD;
&#xD;
      G. The above-mentioned monitor items will be recorded carefully by the research assistants at&#xD;
      three specific time-points during the whole clinic trial program course, which are initial&#xD;
      point (7 days before radiotherapy), medium point (medium date during radiotherapy) and final&#xD;
      point (14 days after radiotherapy).&#xD;
&#xD;
      H. The research assistants will help the patients make an appointment, and let them visit the&#xD;
      doctor on schedule. And make sure the patients actually follow up the suggestions and obey&#xD;
      the instructions during the clinic trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>grade of oral mucositis</measure>
    <time_frame>once a week during radiotherapy and once after radiotherapy up to 8 weeks</time_frame>
    <description>Oral mucositis and radiation-induced dermatological toxicity were evaluated during and after treatment using the National Cancer Institute Common Toxicity Criteria version 3.0 (CTCAE v.3). The scoring was done as the patients went through the treatment by the attending physicians. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>grade of neck dermatitis</measure>
    <time_frame>once a week during radiotherapy and once after radiotherapy up to 8 weeks</time_frame>
    <description>Oral mucositis and radiation-induced dermatological toxicity were evaluated during and after treatment using the National Cancer Institute Common Toxicity Criteria version 3.0 (CTCAE v.3). The scoring was done as the patients went through the treatment by the attending physicians. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>Glutamine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>intake of 5g glutamine and 10g maltodextrin. Oral glutamine is a food additive issued by food and drug government in Taiwan with number 009929.L-Glutamine and maltodextrin are both nutritional supplements. In the glutamine arm: 10 g L-Glutamine and 5 g maltodextrin.&#xD;
The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>intake of 15g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>oral glutamine</intervention_name>
    <description>L-Glutamine and maltodextrin are both nutritional supplements. In the glutamine arm: 10 g L-Glutamine and 5 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.</description>
    <arm_group_label>Glutamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>in the placebo arm: 15 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiotherapy</intervention_name>
    <description>All patients undergo radiotherapy. 5 days a week. All patients had a dental evaluation for good oral hygiene prior to computed tomography simulation for radiotherapy. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. The course of radiation was initiated no more than 6 weeks after resection. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.</description>
    <arm_group_label>Glutamine</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histopathological diagnosis of malignant head and neck tumor.&#xD;
&#xD;
          -  able to open his or her mouth wider than the width of one finger during the assessment&#xD;
             of oral mucositis.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group（ECOG）0-2&#xD;
&#xD;
          -  complete radiotherapy (six to seven weeks with targets involving oral cavity or&#xD;
             oropharynx)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of previous radiotherapy.&#xD;
&#xD;
          -  diabetes or nephritic or hepatic problems.&#xD;
&#xD;
          -  serious infection or sepsis.&#xD;
&#xD;
          -  distant metastases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kaohsihung Medical University Hospital</name>
      <address>
        <city>Kaohsiung</city>
        <zip>80708</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
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  <verification_date>February 2015</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>January 8, 2017</last_update_submitted>
  <last_update_submitted_qc>January 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Glutamine</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/NCT03015077
org study id: KMUHIRB-2014-12-01(II)
nct id: NCT03015077
lead sponsor: 
has dmc: Yes
The rapidly increasing mortality and incidence of oral cancer has become a public health
      major problem in Taiwan. To date, the treatment of head and neck cancer mainly include
      surgery, radiotherapy and chemotherapy. However, radiotherapy and chemotherapy might have an
      influence on the patients' diet by causing dismal side effects, including nausea, vomiting,
      pain, infection, dysorexia, allotriogeustia, oral ulceration and dysphagia, which make the
      patients more difficult to absorb nutrients. In the previous study, the incidence of
      malnutrition among the patients with cancer has been estimated at between 40 and 80%,
      especially occurred in the patients with head and neck cancers and upper gastrointestinal
      cancers.

      In this study, the effect of supplement with L-Glutamine on the nutritional status and
      radiation-induced toxicity of head and neck cancer patients will be evaluated to improve the
      patients' quality of life when they are undergoing radiotherapy. When the head and neck
      cancer patients undergoing radiotherapy, patients' instructions and nutrient intervention of
      L-Glutamine are performed to maintain the patients' nutritional status and reduce the
      patients' diet-related or other side effects caused by radiotherapy. It is anticipated that
      head and neck cancer patients with surgery and radiotherapy intake with L-Glutamine might
      decrease treatment-related side effects and hence improve their quality of life when they are
      undergoing radiotherapy.
1. Written informed consent must be obtained before any study specific procedures are
           undertaken.

        2. The process of the experiment A. head and neck cancer patients with surgery and
           radiotherapy are identified in clinic at the Department of Dentistry and the Department
           of Radiotherapy in Kaohsiung Medical University Chung-Ho Memorial Hospital.

      B. Inform these patients about the value of this clinical trial in detail, and make sure that
      they understand all the meanings of each procedure in this clinical trial. Subsequently, the
      patients who are willing to participate in this study are enrolled after completing
      institutionally approved informed consent.

      C. In order to assess the effect of supplement with L-Glutamine on the nutritional status and
      diet of head and neck cancer patients with surgery and radiotherapy, the enrolled patients
      will be divided into two groups randomly. One group is supplied with 10 g L-Glutamine and 5 g
      maltodextrin; the other group is supplied with 15 g maltodextrin as control group. The
      patients of these two groups take their supplemental nutrients three times a day,
      respectively, in a period of time of 7 days before radiotherapy to 14 days after
      radiotherapy.

      D. Meanwhile, the research assistants will monitor the patients' condition carefully by
      recording their daily diet, nutritional status and side effects caused by radiotherapy at
      three specific time-points during the whole clinic trial program course.

      E. The monitor items of patients' nutritional status include the daily diet of patients
      before and after radiotherapy by recording 24 hr recall table and food frequency table,(b)
      the physical examination of height, weight, ideal weight, tricept skinfold (TSF), mid-arm
      circumference (MAC) and mid-arm muscle circumference (MAMC), (d) prognostic nutritional index
      (PNI), (e) biochemistry inspection assessment and (g) complete blood count (CBC).

      F. The monitor items of patients' diet-related side effects caused by radiotherapy include
      (a) oral mucositis and (b) neck dermatitis.

      G. The above-mentioned monitor items will be recorded carefully by the research assistants at
      three specific time-points during the whole clinic trial program course, which are initial
      point (7 days before radiotherapy), medium point (medium date during radiotherapy) and final
      point (14 days after radiotherapy).

      H. The research assistants will help the patients make an appointment, and let them visit the
      doctor on schedule. And make sure the patients actually follow up the suggestions and obey
      the instructions during the clinic trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: grade of oral mucositis
time frame: once a week during radiotherapy and once after radiotherapy up to 8 weeks
description: Oral mucositis and radiation-induced dermatological toxicity were evaluated during and after treatment using the National Cancer Institute Common Toxicity Criteria version 3.0 (CTCAE v.3). The scoring was done as the patients went through the treatment by the attending physicians. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.
measure: grade of neck dermatitis
time frame: once a week during radiotherapy and once after radiotherapy up to 8 weeks
description: Oral mucositis and radiation-induced dermatological toxicity were evaluated during and after treatment using the National Cancer Institute Common Toxicity Criteria version 3.0 (CTCAE v.3). The scoring was done as the patients went through the treatment by the attending physicians. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.
arm group label: Glutamine
arm group type: Active Comparator
description: intake of 5g glutamine and 10g maltodextrin. Oral glutamine is a food additive issued by food and drug government in Taiwan with number 009929.L-Glutamine and maltodextrin are both nutritional supplements. In the glutamine arm: 10 g L-Glutamine and 5 g maltodextrin.
The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.
arm group label: placebo
arm group type: Placebo Comparator
description: intake of 15g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.
intervention type: Dietary Supplement
intervention name: oral glutamine
description: L-Glutamine and maltodextrin are both nutritional supplements. In the glutamine arm: 10 g L-Glutamine and 5 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.
arm group label: Glutamine
intervention type: Dietary Supplement
intervention name: placebo
description: in the placebo arm: 15 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.
arm group label: placebo
intervention type: Radiation
intervention name: Radiotherapy
description: All patients undergo radiotherapy. 5 days a week. All patients had a dental evaluation for good oral hygiene prior to computed tomography simulation for radiotherapy. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. The course of radiation was initiated no more than 6 weeks after resection. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.
arm group label: Glutamine
arm group label: placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Taiwan
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responsible party type: Sponsor
mesh term: Head and Neck Neoplasms