<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/NCT01707641</url>
  </required_header>
  <id_info>
    <org_study_id>CD2 AIRO</org_study_id>
    <nct_id>NCT01707641</nct_id>
  </id_info>
  <brief_title>Effect of Lactobacillus Brevis CD2 in Prevention of Radio-chemotherapy Induced Oral Mucositis in Head and Neck Cancer</brief_title>
  <official_title>A Randomized Study on the Effects of Lactobacillus Brevis CD2 in the Prevention of Radio and Chemotherapy Induced Oral Mucositis in Head and Neck Cancer Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>S. Andrea Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>S. Andrea Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oral mucositis is a debilitating side effect for oncology patients and there is a clear need&#xD;
      for new therapeutic options. The lozenges containing Lactobacillus brevis CD2 proved a&#xD;
      potential new alternative for the prevention of grade III and IV mucositis. The main endpoint&#xD;
      of this study is to verify if these lozenges taken 6 times a day may reduce the incidence of&#xD;
      grade III and IV mucositis as well as increase the percentage of patients who will complete&#xD;
      the radio-chemotherapy treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mucositis is a debilitating side effect of radio and chemotherapy treatment in oncology&#xD;
      patients. It is not only painful, but also can limit adequate nutritional intake and decrease&#xD;
      the willingness of patients to continue the treatment. Furthermore, extensive mucositis may&#xD;
      require additional nutritional supplementation, and narcotic analgesic increasing the cost of&#xD;
      the therapy. Quality of life is impaired in patients who develop severe mucositis.&#xD;
&#xD;
      Clinically, it begins with asymptomatic redness and erythema and ultimately passing through&#xD;
      different stages to large acutely painful contiguous pseudomembranous lesions with associated&#xD;
      dysphagia and decreased oral intake. The common sites of oral mucositis are labial, buccal,&#xD;
      soft palate, floor of mouth, and the ventral surface of the tongue. The loss of the&#xD;
      epithelial cells exposes the underlying connective tissue with its associated innervations&#xD;
      causing pain. Oral infections, which may be due to bacterial, fungal, or viruses may further&#xD;
      exacerbate the mucositis as well as lead to systemic infections.&#xD;
&#xD;
      Treatment and prevention of therapy related mucositis is essential; unfortunately, the&#xD;
      efficacy and safety of most of the regimen used have not been clearly established.&#xD;
      Prophylactic measures employed are use of: chlorhexidine, saline rinses, soda bicarbonate&#xD;
      rinses, acyclovir, and ice. For treatment of mucositis and its associated pain local&#xD;
      anesthetic, diphenhydramine, nystatin, or sucralfate are used alone or in combination as&#xD;
      mouthwash. Oral or parenteral narcotics are also used for pain relief.&#xD;
&#xD;
      There is a clear need for new therapeutic options for oral mucositis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 4</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of grade III/IV mucositis</measure>
    <time_frame>2 months</time_frame>
    <description>Evaluation of the grade III and IV mucositis incidence in patients undergoing chemo-radiotherapy and taking CD#2 or standard therapy (bicarbonate sodium mouthwash)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>percentage of patients able to complete the chemo-radiotherapy treatment</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>percentage of patients who need enteral nutrition</measure>
    <time_frame>2 months from enrolment</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Mucositis</condition>
  <arm_group>
    <arm_group_label>CD#2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>bicarbonate sodium mouthwash</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>patients will be asked to wash their mouth with bicarbonate several times per day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>CD#2</intervention_name>
    <description>patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth</description>
    <arm_group_label>CD#2</arm_group_label>
    <other_name>Lozenge containing Lactobacillus brevis CD2</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>bicarbonate sodium mouthwash</intervention_name>
    <description>Patients will be asked to wash their mouth with bicarbonate sodium several times per day</description>
    <arm_group_label>bicarbonate sodium mouthwash</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male and female patients &gt; 18 years of age&#xD;
&#xD;
          -  Karnofsky Performance Status &gt;70%&#xD;
&#xD;
          -  pathological and histological diagnosis that confirms head and neck tumour&#xD;
&#xD;
          -  patients eligible for radical radiotherapy and/or chemotherapy&#xD;
&#xD;
          -  expected survival time &gt; 6 months&#xD;
&#xD;
          -  normal bone marrow function (neutrophil count &gt;1500/cmm, platelet count &gt; 100.000/CMM)&#xD;
&#xD;
          -  serum creatine &lt; 1.8mg/dl&#xD;
&#xD;
          -  total bilirubin &lt;2mg/dl&#xD;
&#xD;
          -  GOT, GPT within 3 times the normal limit&#xD;
&#xD;
          -  willingness to perform conventional 3D radiotherapy or intensive modulated radiation&#xD;
             therapy with concurrent chemotherapy&#xD;
&#xD;
          -  signed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of glottic tumour, parotid or salivary, larynx tumour.&#xD;
&#xD;
          2. Presence of metastasis, detected with contrast-enhances TC TB and/or PET/TC&#xD;
&#xD;
          3. Major surgery of the oral cavity within the last 4 weeks&#xD;
&#xD;
          4. Patients previoucly treated with radiotherapy of head and neck&#xD;
&#xD;
          5. Antifungal or antiviral therapy for oral pathological conditions in the last&#xD;
&#xD;
          6. Other serious concomitant disease&#xD;
&#xD;
          7. History of insulin-dependent Diabetes Mellituss&#xD;
&#xD;
          8. History of oral ulceration, herpes simplex, oral candidiasis, severe gingivitis,&#xD;
             active or chronic mucositis or Xerostomia&#xD;
&#xD;
          9. Patients with body weigh &gt;35 kg&#xD;
&#xD;
         10. Women of childbearing potential who are pregnant, breast-feeding or intend to become&#xD;
             pregnant&#xD;
&#xD;
         11. Patients with Hepatitis B / C&#xD;
&#xD;
         12. Patients with symptomatic untreated dental infection&#xD;
&#xD;
         13. Patients with oral mucositis grade NCICTC 3 or 4&#xD;
&#xD;
         14. Histological and pathological diagnosis unavailable&#xD;
&#xD;
         15. Patients with signs and symptoms of systemic infection&#xD;
&#xD;
         16. Patient's refusal to sign the informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vitaliana De Sanctis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sant'Andrea Hospital - Radiotherapy Unit</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vitaliana De Sanctis, PhD</last_name>
    <email>vitaliana.desanctis@uniroma1.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sant'Andrea Hospital</name>
      <address>
        <city>Rome</city>
        <zip>00189</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vitaliana De Sanctis, PhD</last_name>
      <email>vitaliana.desanctis@uniroma1.it</email>
    </contact>
    <investigator>
      <last_name>Vitaliana De Sanctis, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>May 19, 2014</last_update_submitted>
  <last_update_submitted_qc>May 19, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>S. Andrea Hospital</investigator_affiliation>
    <investigator_full_name>Vitaliana De Sanctis</investigator_full_name>
    <investigator_title>M.D. University Researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
    <mesh_term>Mucositis</mesh_term>
    <mesh_term>Stomatitis</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/NCT01707641
org study id: CD2 AIRO
nct id: NCT01707641
lead sponsor: 
has dmc: No
Oral mucositis is a debilitating side effect for oncology patients and there is a clear need
      for new therapeutic options. The lozenges containing Lactobacillus brevis CD2 proved a
      potential new alternative for the prevention of grade III and IV mucositis. The main endpoint
      of this study is to verify if these lozenges taken 6 times a day may reduce the incidence of
      grade III and IV mucositis as well as increase the percentage of patients who will complete
      the radio-chemotherapy treatment.
Mucositis is a debilitating side effect of radio and chemotherapy treatment in oncology
      patients. It is not only painful, but also can limit adequate nutritional intake and decrease
      the willingness of patients to continue the treatment. Furthermore, extensive mucositis may
      require additional nutritional supplementation, and narcotic analgesic increasing the cost of
      the therapy. Quality of life is impaired in patients who develop severe mucositis.

      Clinically, it begins with asymptomatic redness and erythema and ultimately passing through
      different stages to large acutely painful contiguous pseudomembranous lesions with associated
      dysphagia and decreased oral intake. The common sites of oral mucositis are labial, buccal,
      soft palate, floor of mouth, and the ventral surface of the tongue. The loss of the
      epithelial cells exposes the underlying connective tissue with its associated innervations
      causing pain. Oral infections, which may be due to bacterial, fungal, or viruses may further
      exacerbate the mucositis as well as lead to systemic infections.

      Treatment and prevention of therapy related mucositis is essential; unfortunately, the
      efficacy and safety of most of the regimen used have not been clearly established.
      Prophylactic measures employed are use of: chlorhexidine, saline rinses, soda bicarbonate
      rinses, acyclovir, and ice. For treatment of mucositis and its associated pain local
      anesthetic, diphenhydramine, nystatin, or sucralfate are used alone or in combination as
      mouthwash. Oral or parenteral narcotics are also used for pain relief.

      There is a clear need for new therapeutic options for oral mucositis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: incidence of grade III/IV mucositis
time frame: 2 months
description: Evaluation of the grade III and IV mucositis incidence in patients undergoing chemo-radiotherapy and taking CD#2 or standard therapy (bicarbonate sodium mouthwash)
measure: percentage of patients able to complete the chemo-radiotherapy treatment
time frame: 2 months
measure: percentage of patients who need enteral nutrition
time frame: 2 months from enrolment
arm group label: CD#2
arm group type: Active Comparator
description: patients will be asked to melt slowly in the mouth 6 lozenges per day, containing Lactobacillus brevis CD2
arm group label: bicarbonate sodium mouthwash
arm group type: Active Comparator
description: patients will be asked to wash their mouth with bicarbonate several times per day
intervention type: Dietary Supplement
intervention name: CD#2
description: patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth
arm group label: CD#2
other name: Lozenge containing Lactobacillus brevis CD2
intervention type: Other
intervention name: bicarbonate sodium mouthwash
description: Patients will be asked to wash their mouth with bicarbonate sodium several times per day
arm group label: bicarbonate sodium mouthwash
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vitaliana De Sanctis, PhD
role: Principal Investigator
affiliation: Sant'Andrea Hospital - Radiotherapy Unit
last name: Vitaliana De Sanctis, PhD
email: vitaliana.desanctis@uniroma1.it
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: S. Andrea Hospital
investigator full name: Vitaliana De Sanctis
investigator title: M.D. University Researcher
mesh term: Head and Neck Neoplasms
mesh term: Mucositis
mesh term: Stomatitis