<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/NCT04463459</url>
  </required_header>
  <id_info>
    <org_study_id>BSMMU/2019/8874</org_study_id>
    <nct_id>NCT04463459</nct_id>
  </id_info>
  <brief_title>Effect of Vitamin C and E in Breast Cancer Patients Undergoing Chemotherapy</brief_title>
  <official_title>Effect of Vitamin C and Vitamin E in Breast Cancer Patients Undergoing Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</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>
      Title:&#xD;
&#xD;
      Effect of Vitamin C and Vitamin E in Breast Cancer patients undergoing Chemotherapy.&#xD;
&#xD;
      Purpose of the study:&#xD;
&#xD;
      The present study has been designed to assess the effects of vitamin C and vitamin E&#xD;
      superimposed upon chemotherapeutic agents where the antioxidant vitamin C and vitamin E would&#xD;
      be concurrently applied to breast cancer patients.&#xD;
&#xD;
      Method:&#xD;
&#xD;
      The study would be a quasi-experimental study involving breast cancer patients and would be&#xD;
      conducted in the Department of Pharmacology and Department of Oncology, BSMMU, from March&#xD;
      2019 to August 2020. A total of 80 breast cancer patients would be selected by abiding&#xD;
      selective inclusion and exclusion criteria. After completing necessary formalities including&#xD;
      informed written consent of the patients, patient's requisite data will be collected. The&#xD;
      diagnosed patients would be randomly allocated into two groups: group A (control group) and&#xD;
      group B (intervention group). Group A would consist of 40 patients who will receive&#xD;
      chemotherapy and group B would consist of 40 patients who will receive vitamin C (1000 mg)&#xD;
      and vitamin E (400 mg) orally daily along with chemotherapy. Both groups would receive&#xD;
      treatment for 8 weeks. Comparison between the two groups would be performed through&#xD;
      biochemical parameters such as total antioxidant capacity (TAC) and total oxidant status&#xD;
      (TOS) at baseline (before vitamin C and vitamin E supplementation) and 6 weeks after&#xD;
      intervention by vitamin C and E supplementationtation.&#xD;
&#xD;
      Ethical consideration:&#xD;
&#xD;
      The study will follow the principles of the Declaration of Helsinki and the World Medical&#xD;
      Assembly. Patients will be informed about the study in easy language and then informed&#xD;
      consent will be taken. This study has no potential risk to the patients. Confidentiality will&#xD;
      be strictly maintained.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer is a devastating cancer having multifactorial origin. It is the most common&#xD;
      cancer and second leading cause of death in women. Every year more than one million breast&#xD;
      cancer patients are diagnosed throughout the world and it has been assumed that among them&#xD;
      more than 410000 would die due to the disease. In our country due to the absence of official&#xD;
      registry records, not much information about breast cancer. 12764 new cases of breast cancer&#xD;
      were diagnosed and 6846 women died in Bangladesh in the year 2018. In low- and middle-income&#xD;
      countries including Bangladesh due to lower resource settings women with breast cancer may&#xD;
      receive inadequate treatment, palliative care or pain relief. The study would be a&#xD;
      quasi-experimental study involving breast cancer patients and would be conducted in the&#xD;
      Department of Pharmacology and Department of Oncology, BSMMU, from March 2019 to August 2020.&#xD;
      A total of 80 breast cancer patients would be selected by abiding selective inclusion and&#xD;
      exclusion criteria. After completing necessary formalities including informed written consent&#xD;
      of the patients, patient's requisite data will be collected. The diagnosed patients would be&#xD;
      randomly allocated into two groups: group A (control group) and group B (intervention group).&#xD;
      Group A would consist of 40 patients who will receive chemotherapy and group B would consist&#xD;
      of 40 patients who will receive vitamin C (1000 mg) and vitamin E (400 mg) orally daily along&#xD;
      with chemotherapy. Both groups would receive treatment for 8 weeks. Comparison between the&#xD;
      two groups would be performed through biochemical parameters such as total antioxidant&#xD;
      capacity (TAC) and total oxidant status (TOS) at baseline (before vitamin C and vitamin E&#xD;
      supplementation) and 6 weeks after intervention by vitamin C and E supplementationtation.&#xD;
      Statistical analysis will be obtained by SPSS (Statistical Package for Social Science)&#xD;
      version 20. Results will be presented in tables and figures as applicable. Calculated 'P'&#xD;
      value may suggest the level of significance (significant at P˂0.05, 0.01 and 0.001). Patients&#xD;
      will be informed about the study in easy language and then informed consent will be taken.&#xD;
      This study has no potential risk to the patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 10, 2019</start_date>
  <completion_date type="Anticipated">September 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 20, 2020</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To measure the serum level of MDA and RBC glutathione in breast cancer patients receiving chemotherapy and following administration of vitamin C and vitamin E concurrent to chemotherapy.</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Chemotherapy + Placebo</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients receiving chemotherapy This group will be received chemotherapy and placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy + Vitamin C + Vitamin E</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receiving vitamin C and E with Chemotherapy This group will be received vitamin C (500 mg) twice daily and vitamin E (400 mg) once daily with chemotherapy for 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamin C, Vitamin E</intervention_name>
    <description>Vitamin C (500mg) twice daily and Vitamin E (400mg) once daily</description>
    <arm_group_label>Chemotherapy + Vitamin C + Vitamin E</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Breast cancer patient before starting chemotherapy and will agree to take protocol&#xD;
             based chemotherapy.&#xD;
&#xD;
          -  Age: 30-70 years.&#xD;
&#xD;
          -  Gender: Female.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients receiving chemotherapy prior to attend the Department of Oncology, BSMMU.&#xD;
&#xD;
          -  Users of any antioxidant nutrient (e g. vitamin A, vitamin C or vitamin E) which can&#xD;
             interfere with concentration of endogenous antioxidant estimation.&#xD;
&#xD;
          -  Patients with impaired renal and hepatic function.&#xD;
&#xD;
          -  Patients with systemic illness such as diabetes, hypertension.&#xD;
&#xD;
          -  Presence of any malignancy other than breast cancer.&#xD;
&#xD;
          -  Mentally sick patient.&#xD;
&#xD;
          -  Smoker.&#xD;
&#xD;
          -  Patient suffering from alcohol or substance abuse or dependence.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fatisha Khanam, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>BSMMU(Recruting), Dhaka-1000, Bangladesh</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fatisha Khanam, MBBS</last_name>
    <phone>01675599917</phone>
    <email>fatisha.khanam@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amirul Islam, MBBS</last_name>
    <phone>01611118008</phone>
    <email>amirul.pavel@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>BSMMU</name>
      <address>
        <city>Dhaka</city>
        <country>Bangladesh</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fatisha Khanam, MBBS</last_name>
      <phone>01675599917</phone>
      <email>fatisha.khanam@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Amirul Pavel, MBBS</last_name>
      <phone>01611118008</phone>
      <email>amirul.pavel@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 4, 2020</last_update_submitted>
  <last_update_submitted_qc>July 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh</investigator_affiliation>
    <investigator_full_name>Dr. Fatisha Khanam</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Vitamin C</keyword>
  <keyword>Vitamin E</keyword>
  <keyword>Breast cancer</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>MDA</keyword>
  <keyword>RBC Glutathione</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Vitamin E</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04463459
org study id: BSMMU/2019/8874
nct id: NCT04463459
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Title:

      Effect of Vitamin C and Vitamin E in Breast Cancer patients undergoing Chemotherapy.

      Purpose of the study:

      The present study has been designed to assess the effects of vitamin C and vitamin E
      superimposed upon chemotherapeutic agents where the antioxidant vitamin C and vitamin E would
      be concurrently applied to breast cancer patients.

      Method:

      The study would be a quasi-experimental study involving breast cancer patients and would be
      conducted in the Department of Pharmacology and Department of Oncology, BSMMU, from March
      2019 to August 2020. A total of 80 breast cancer patients would be selected by abiding
      selective inclusion and exclusion criteria. After completing necessary formalities including
      informed written consent of the patients, patient's requisite data will be collected. The
      diagnosed patients would be randomly allocated into two groups: group A (control group) and
      group B (intervention group). Group A would consist of 40 patients who will receive
      chemotherapy and group B would consist of 40 patients who will receive vitamin C (1000 mg)
      and vitamin E (400 mg) orally daily along with chemotherapy. Both groups would receive
      treatment for 8 weeks. Comparison between the two groups would be performed through
      biochemical parameters such as total antioxidant capacity (TAC) and total oxidant status
      (TOS) at baseline (before vitamin C and vitamin E supplementation) and 6 weeks after
      intervention by vitamin C and E supplementationtation.

      Ethical consideration:

      The study will follow the principles of the Declaration of Helsinki and the World Medical
      Assembly. Patients will be informed about the study in easy language and then informed
      consent will be taken. This study has no potential risk to the patients. Confidentiality will
      be strictly maintained.
Breast cancer is a devastating cancer having multifactorial origin. It is the most common
      cancer and second leading cause of death in women. Every year more than one million breast
      cancer patients are diagnosed throughout the world and it has been assumed that among them
      more than 410000 would die due to the disease. In our country due to the absence of official
      registry records, not much information about breast cancer. 12764 new cases of breast cancer
      were diagnosed and 6846 women died in Bangladesh in the year 2018. In low- and middle-income
      countries including Bangladesh due to lower resource settings women with breast cancer may
      receive inadequate treatment, palliative care or pain relief. The study would be a
      quasi-experimental study involving breast cancer patients and would be conducted in the
      Department of Pharmacology and Department of Oncology, BSMMU, from March 2019 to August 2020.
      A total of 80 breast cancer patients would be selected by abiding selective inclusion and
      exclusion criteria. After completing necessary formalities including informed written consent
      of the patients, patient's requisite data will be collected. The diagnosed patients would be
      randomly allocated into two groups: group A (control group) and group B (intervention group).
      Group A would consist of 40 patients who will receive chemotherapy and group B would consist
      of 40 patients who will receive vitamin C (1000 mg) and vitamin E (400 mg) orally daily along
      with chemotherapy. Both groups would receive treatment for 8 weeks. Comparison between the
      two groups would be performed through biochemical parameters such as total antioxidant
      capacity (TAC) and total oxidant status (TOS) at baseline (before vitamin C and vitamin E
      supplementation) and 6 weeks after intervention by vitamin C and E supplementationtation.
      Statistical analysis will be obtained by SPSS (Statistical Package for Social Science)
      version 20. Results will be presented in tables and figures as applicable. Calculated 'P'
      value may suggest the level of significance (significant at P˂0.05, 0.01 and 0.001). Patients
      will be informed about the study in easy language and then informed consent will be taken.
      This study has no potential risk to the patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: To measure the serum level of MDA and RBC glutathione in breast cancer patients receiving chemotherapy and following administration of vitamin C and vitamin E concurrent to chemotherapy.
time frame: 6 weeks
arm group label: Chemotherapy + Placebo
arm group type: No Intervention
description: Patients receiving chemotherapy This group will be received chemotherapy and placebo
arm group label: Chemotherapy + Vitamin C + Vitamin E
arm group type: Active Comparator
description: Patients receiving vitamin C and E with Chemotherapy This group will be received vitamin C (500 mg) twice daily and vitamin E (400 mg) once daily with chemotherapy for 6 weeks
intervention type: Drug
intervention name: Vitamin C, Vitamin E
description: Vitamin C (500mg) twice daily and Vitamin E (400mg) once daily
arm group label: Chemotherapy + Vitamin C + Vitamin E
criteria: 
gender: Female
gender based: Yes
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Fatisha Khanam, MBBS
role: Principal Investigator
affiliation: BSMMU(Recruting), Dhaka-1000, Bangladesh
last name: Fatisha Khanam, MBBS
phone: 01675599917
email: fatisha.khanam@gmail.com
last name: Amirul Islam, MBBS
phone: 01611118008
email: amirul.pavel@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Bangladesh
responsible party type: Principal Investigator
investigator affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
investigator full name: Dr. Fatisha Khanam
investigator title: Principal Investigator
mesh term: Breast Neoplasms
mesh term: Vitamins
mesh term: Vitamin E
sharing ipd: No