xml: <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/NCT06015087</url>
    </required_header>
    <id_info>
      <org_study_id>Fasting diet</org_study_id>
      <nct_id>NCT06015087</nct_id>
    </id_info>
    <brief_title>Evaluation of the Influence of Short Term Fasting Diet on Chemotherapy-induced Toxicities in Breast Cancer Patients</brief_title>
    <official_title>Fasting Diet and Chemotherapy Toxicity</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Thessaly</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Thessaly</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy -&#xD;
        induced toxicities in breast cancer patients. The study will have an intevention group and a&#xD;
        control group. The intervention group will follow a fasting diet of 60 hours (36h prior&#xD;
        chemotherapy and 24h after the end of chemotherary), while the control group will follow&#xD;
        regular (standard) diet. At the meantime of the chemotherapy cycles, the intervention group&#xD;
        will be recommended to follow the Mediterranean diet.&#xD;
  &#xD;
        The main questions this study is aiming to answer is whether short term fasting diet&#xD;
        influences chemotherary - induced toxicities and if it is easy to be implemented.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy -&#xD;
        induced toxicities in breast cancer patients. The study will have an intevention group and a&#xD;
        control group. The intervention group will follow a fasting diet for 60 hours (36h prior&#xD;
        chemotherapy and 24h after the end of chemotherapy), while the control group will follow&#xD;
        regular diet. At the meantime of the chemotherapy cycles, the intervention group will be&#xD;
        recommended to follow the Mediterranean diet. The patients will be randomized in the two&#xD;
        groups. A total of 50 patients is required. Biochemical data, anthropometric measures and&#xD;
        grading of toxicity according to National Cancer Institute Common Terminology Criteria for&#xD;
        Adverse Events, nutritional habits, adherence to the Mediterranean diet (implementation of&#xD;
        MedDietScore) will be assessed prior, during and after the intervention, in both groups.&#xD;
        Nutritional counseling will be performed by Registered Dietitian, and telephone interviews&#xD;
        will be used to record adherence to fasting diet and Mediterranean diet.&#xD;
  &#xD;
        The main questions this study is aiming to answer is whether short term fasting diet&#xD;
        influences chemotherary - induced toxicities and if it is easy to be implemented.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2022</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">July 2024</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluation of the influence of short term fasting diet on the incidence of treatment-emergent adverse events [safety and tolerability]) caused by chemotherapy</measure>
      <time_frame>Participants will be followed from date of randomization until one month after the last chemotherapy.</time_frame>
      <description>Grade of toxicity will be accessed after each chempotherapy, using the National Cancer Institute Common Terminology Criteria for Adverse Events and eorct. Comparison between the two groups will be performed after each chemotherapy cycle.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Fasting, Diet, Chemotherapy, Toxicity</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>fasting diet</intervention_name>
      <description>A total of 50 patients with breast cancer will be randomly devided in intervention and control group. Intervention group will follow a 60 hours fasting diet (36h prior and 24h after chemotherapy infusion), low in calories, mainly plant based, and the Mediterranean Diet in the meantime between chemotherapy cycles. Control group will receive only standard of care. Nutritional counseling and dietary records will be performed by registered dietitian. Adherence to the Mediterranean Diet will be estimated with MedDietScore. Grade of toxicity will be estimated by using the National Cancer Institute Common Terminology Criteria for Adverse Events. All participants will be encourange to continue usual physical activity.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  breast cancer patients with first diagnosis of breast cancer&#xD;
  &#xD;
            -  no distinct metastasis&#xD;
  &#xD;
            -  patients will receive at least 4 cycles of adjuvant or neo-adjuvant chemotherapy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  BMI&lt;19kg/m2&#xD;
  &#xD;
            -  unintentional weight loss of &gt;3 or &gt;5 kg the last 3 or 6 months respectively&#xD;
  &#xD;
            -  medical history of anorexia nervosa, boulimia or any other eating disorders&#xD;
  &#xD;
            -  renal failure (creatinine &gt;2mg/dl)&#xD;
  &#xD;
            -  diabetes mellitus (type I or Insulin dependent type II)&#xD;
  &#xD;
            -  serious psychiatric disease&#xD;
  &#xD;
            -  serious cardiovascular disease&#xD;
  &#xD;
            -  mobility limitations&#xD;
  &#xD;
            -  being participant in any other study&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Department of Nutrition-Dietetics</name>
        <address>
          <city>Tríkala</city>
          <state>Thessaly</state>
          <zip>42132</zip>
          <country>Greece</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Odysseas Androutsos, PhD</last_name>
        <phone>00306944290774</phone>
        <email>oandroutsos@uth.gr</email>
      </contact>
      <contact_backup>
        <last_name>Niki Kontou, PhD</last_name>
        <phone>00306972668912</phone>
        <email>niki.kontou@yahoo.gr</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Greece</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Thessaly</investigator_affiliation>
      <investigator_full_name>Odysseas Androutsos</investigator_full_name>
      <investigator_title>Associate Professor of Clinical Nutrition and Dietetics</investigator_title>
    </responsible_party>
    <keyword>fasting diet, breast cancer, chemotherapy toxicity, Mediterranean Diet</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06015087
  org study id: Fasting diet
  nct id: NCT06015087
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy -
        induced toxicities in breast cancer patients. The study will have an intevention group and a
        control group. The intervention group will follow a fasting diet of 60 hours (36h prior
        chemotherapy and 24h after the end of chemotherary), while the control group will follow
        regular (standard) diet. At the meantime of the chemotherapy cycles, the intervention group
        will be recommended to follow the Mediterranean diet.
  
        The main questions this study is aiming to answer is whether short term fasting diet
        influences chemotherary - induced toxicities and if it is easy to be implemented.
  This is a clinical trial aiming to assess the effect of fasting diet on chemotherapy -
        induced toxicities in breast cancer patients. The study will have an intevention group and a
        control group. The intervention group will follow a fasting diet for 60 hours (36h prior
        chemotherapy and 24h after the end of chemotherapy), while the control group will follow
        regular diet. At the meantime of the chemotherapy cycles, the intervention group will be
        recommended to follow the Mediterranean diet. The patients will be randomized in the two
        groups. A total of 50 patients is required. Biochemical data, anthropometric measures and
        grading of toxicity according to National Cancer Institute Common Terminology Criteria for
        Adverse Events, nutritional habits, adherence to the Mediterranean diet (implementation of
        MedDietScore) will be assessed prior, during and after the intervention, in both groups.
        Nutritional counseling will be performed by Registered Dietitian, and telephone interviews
        will be used to record adherence to fasting diet and Mediterranean diet.
  
        The main questions this study is aiming to answer is whether short term fasting diet
        influences chemotherary - induced toxicities and if it is easy to be implemented.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Evaluation of the influence of short term fasting diet on the incidence of treatment-emergent adverse events [safety and tolerability]) caused by chemotherapy
  time frame: Participants will be followed from date of randomization until one month after the last chemotherapy.
  description: Grade of toxicity will be accessed after each chempotherapy, using the National Cancer Institute Common Terminology Criteria for Adverse Events and eorct. Comparison between the two groups will be performed after each chemotherapy cycle.
  arm group label: Intervention group
  arm group type: Experimental
  arm group label: Control group
  arm group type: No Intervention
  intervention type: Other
  intervention name: fasting diet
  description: A total of 50 patients with breast cancer will be randomly devided in intervention and control group. Intervention group will follow a 60 hours fasting diet (36h prior and 24h after chemotherapy infusion), low in calories, mainly plant based, and the Mediterranean Diet in the meantime between chemotherapy cycles. Control group will receive only standard of care. Nutritional counseling and dietary records will be performed by registered dietitian. Adherence to the Mediterranean Diet will be estimated with MedDietScore. Grade of toxicity will be estimated by using the National Cancer Institute Common Terminology Criteria for Adverse Events. All participants will be encourange to continue usual physical activity.
  arm group label: Intervention group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Greece
  responsible party type: Principal Investigator
  investigator affiliation: University of Thessaly
  investigator full name: Odysseas Androutsos
  investigator title: Associate Professor of Clinical Nutrition and Dietetics
  sharing ipd: Undecided