<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/NCT02190539</url>
  </required_header>
  <id_info>
    <org_study_id>0050-14-MMC</org_study_id>
    <nct_id>NCT02190539</nct_id>
  </id_info>
  <brief_title>Homeopathic Protocol for Advanced Breast Cancer</brief_title>
  <official_title>The Banerji Protocol for Advanced Breast Cancer- Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The objective of this study is to conduct a feasibility study at Meir Oncology Institute&#xD;
      examining whether patients with advanced breast cancer would follow a homeopathic protocol&#xD;
      for three to six months.&#xD;
&#xD;
      The primary aim of the study is to establish if patients with advanced breast cancer in Meir&#xD;
      Oncology Institute would follow a regimen of treatment as used by Dr Banerji in India, for&#xD;
      six months.&#xD;
&#xD;
      The secondary aim is to observe the quality of life and wellbeing of patients undergoing this&#xD;
      protocol&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      - Homeopathy is a controversial system of care and at the center of the controversy lays the&#xD;
      question of whether high dilution remedies can be effective.&#xD;
&#xD;
      There have been only a handful of high quality studies of homeopathy on the treatment of&#xD;
      cancer, despite its widespread use for this condition.&#xD;
&#xD;
      In a recent prospective observational study done in Germany with cancer patients in two&#xD;
      differently treated cohorts it was observed that an improvement in quality of life was&#xD;
      observed in patients taking the addition of homeopathic treatment. In the laboratory,&#xD;
      research on homeopathy and cancer that does exist is limited but has some clues for effects&#xD;
      that cannot be ignored. A study that was conducted at The University of Texas MD Anderson&#xD;
      Cancer Center, revealed that four ultradilute remedies (Carcinosin, Phytolacca, Conium, and&#xD;
      Thuja) exerted preferential cytotoxic effects against two breast cancer cell lines, causing&#xD;
      cell cycle delay/arrest and apoptosis without affecting the normal mammary epithelial cells.&#xD;
      Since patients with advanced breast cancer are the highest CAM users amongst patients&#xD;
      affected by cancer, it was thought that a feasibility study with this group of patients,&#xD;
      would be a rational first step in proceeding to evaluate this controversial method of care,&#xD;
      if it has merit or not.&#xD;
&#xD;
        -  The objective of this study is to conduct a feasibility study at Meir Oncology Institute&#xD;
           examining whether patients with advanced breast cancer would follow a homeopathic&#xD;
           protocol for three to six months. The primary aim of the study is to establish if&#xD;
           patients with advanced breast cancer in Meir Oncology Institute would follow homeopathic&#xD;
           protocol as used by Dr Banerji in India, for six months. The secondary aim is to observe&#xD;
           the quality of life and wellbeing of patients undergoing this protocol.&#xD;
&#xD;
        -  Patients with the diagnosis of advanced breast cancer who attend the Meir Oncology&#xD;
           Institute clinic will be offered by their treating physician or nurse a fact sheet about&#xD;
           this study and will be asked to participate in this protocol. The protocol will be&#xD;
           explained to the patient by the research team. If they agree to participate they will be&#xD;
           given a consent form to sign, and basic information will be obtained from each patient.&#xD;
           This information will include basic demographics (age, marital status, employment ,&#xD;
           education level) and basic medical information ( Disease status and progress, current&#xD;
           symptoms, medications and treatments being used, complementary medicine being used) as&#xD;
           well as evaluation of quality of life using the European Organization for Research and&#xD;
           Treatment of Cancer (EORTC) quality of life questionnaire (QLQ).&#xD;
&#xD;
        -  Patients will receive the selected homeopathic remedies (Carcinosin 30C, Phytolacca&#xD;
           200C, and Thuja 30C) with written instructions about the proper use of the remedies. The&#xD;
           remedies will be offered to patients in addition to their regular conventional care.&#xD;
           Patients that cannot participate in conventional cancer care due to side effects,&#xD;
           expected adverse reactions or other reasons that prevent them from utilizing&#xD;
           conventional care will be offered to participate in the study, as well. In addition,&#xD;
           patients who for their own reasons elect to refuse conventional treatment can be offered&#xD;
           to participate in the study in order to keep them in the system and not lose them to&#xD;
           alternative untested treatments. Every 4 weeks for the period of 3 months and once at 6&#xD;
           months, a research assistant/ research nurse will contact each participant to review&#xD;
           EORTC QLQ- C-30 questionnaire to evaluate quality of life as well as a follow up&#xD;
           questionnaire which will verify the actual use of these remedies, perceived problems in&#xD;
           taking these remedies, utilization of other therapies, address patients concerns, and&#xD;
           document disease progression. A total of 30 patients will be enrolled in this study and&#xD;
           their data will be reviewed and analyzed six months after recruitment to the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not able to recruit patients&#xD;
  </why_stopped>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">August 2019</completion_date>
  <primary_completion_date type="Actual">August 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To establish if patients with advanced breast cancer in Meir Oncology Institute would follow a homeopathic treatment protocol as used by Dr Banerji in India, for six months.</measure>
    <time_frame>Six months</time_frame>
    <description>Investigators will follow patients with advanced breast cancer in Meir Oncology Institute and see if patients would follow a homeopathic treatment protocol as used by Dr Banerji in India, for six months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Observe and verify the quality of life and wellbeing of patients undergoing this protocol</measure>
    <time_frame>Six months</time_frame>
    <description>Investigators will document the quality of life and wellbeing of patients undergoing this protocol utilizing the EORTC QLQ-C30 (a questionnaire developed to assess the quality of life of cancer patients).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Homeopathic treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A feasibility study examining whether patients with advanced breast cancer would follow a homeopathic protocol for three to six months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Homeopathic treatment</intervention_name>
    <description>Remedies are sold over the counter without a physician prescription (approved by the Israeli Ministry of Health). No toxicity or side effects are expected to be observed, potencies (dilutions) of substances beyond 7C (7 dilutions, each 1:100) do not contain a sufficient number of molecules of the original material to be pharmacologically active. Since the remedies being used in this trial are diluted at 30c and 200c, levels that are way beyond Avogrado's number, so no original material is expected to be found. This fact was verified utilizing high pressure liquid chromatography (HPLC) method. Due to those facts, most scientists do not accept that these remedies have any biological effects and consign any positive response to the placebo effect.</description>
    <arm_group_label>Homeopathic treatment</arm_group_label>
    <other_name>A combined treatment of three homeopathic remedies:</other_name>
    <other_name>Phytolacca 200C</other_name>
    <other_name>Thuja 30C</other_name>
    <other_name>Carcinosin 30c</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Ability to speak and read Hebrew/English with patients residing in Israel.&#xD;
&#xD;
          -  Diagnosis of advanced breast cancer treated and followed in Meir Oncology Institute&#xD;
&#xD;
          -  Patients that cannot participate in conventional cancer care due to side effects,&#xD;
             expected adverse reactions or other reasons that prevent them from utilizing&#xD;
             conventional care.&#xD;
&#xD;
          -  Patients, who for their own reasons elect to refuse conventional treatment, can be&#xD;
             offered to participate in the study in order to keep them in the system and not lose&#xD;
             them to alternative untested treatments.&#xD;
&#xD;
          -  Consent to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to understand the intent of the study and follow the instructions&#xD;
&#xD;
          -  Medical condition that would preclude participation in an interview session lasting&#xD;
             15-30 minutes&#xD;
&#xD;
          -  Diagnosis of active psychosis or severe cognitive impairment confirmed by the&#xD;
             patient's attending physician.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moshe Frenkel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institute of Oncology Meir Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Oncology Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <link>
    <url>http://www.moshefrenkelmd.com/index.asp?page=2171&amp;lang=eng</url>
    <description>Integrative Oncology - Homeopathy</description>
  </link>
  <results_reference>
    <citation>Frenkel M, Mishra BM, Sen S, Yang P, Pawlus A, Vence L, Leblanc A, Cohen L, Banerji P, Banerji P. Cytotoxic effects of ultra-diluted remedies on breast cancer cells. Int J Oncol. 2010 Feb;36(2):395-403.</citation>
    <PMID>20043074</PMID>
  </results_reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>August 12, 2019</last_update_submitted>
  <last_update_submitted_qc>August 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>Moshe Frenkel</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>complementary medicine</keyword>
  <keyword>homeopathy</keyword>
  <keyword>quality of life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Publications, Presentations in international meetings</ipd_description>
  </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/NCT02190539
org study id: 0050-14-MMC
nct id: NCT02190539
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to conduct a feasibility study at Meir Oncology Institute
      examining whether patients with advanced breast cancer would follow a homeopathic protocol
      for three to six months.

      The primary aim of the study is to establish if patients with advanced breast cancer in Meir
      Oncology Institute would follow a regimen of treatment as used by Dr Banerji in India, for
      six months.

      The secondary aim is to observe the quality of life and wellbeing of patients undergoing this
      protocol
- Homeopathy is a controversial system of care and at the center of the controversy lays the
      question of whether high dilution remedies can be effective.

      There have been only a handful of high quality studies of homeopathy on the treatment of
      cancer, despite its widespread use for this condition.

      In a recent prospective observational study done in Germany with cancer patients in two
      differently treated cohorts it was observed that an improvement in quality of life was
      observed in patients taking the addition of homeopathic treatment. In the laboratory,
      research on homeopathy and cancer that does exist is limited but has some clues for effects
      that cannot be ignored. A study that was conducted at The University of Texas MD Anderson
      Cancer Center, revealed that four ultradilute remedies (Carcinosin, Phytolacca, Conium, and
      Thuja) exerted preferential cytotoxic effects against two breast cancer cell lines, causing
      cell cycle delay/arrest and apoptosis without affecting the normal mammary epithelial cells.
      Since patients with advanced breast cancer are the highest CAM users amongst patients
      affected by cancer, it was thought that a feasibility study with this group of patients,
      would be a rational first step in proceeding to evaluate this controversial method of care,
      if it has merit or not.

        -  The objective of this study is to conduct a feasibility study at Meir Oncology Institute
           examining whether patients with advanced breast cancer would follow a homeopathic
           protocol for three to six months. The primary aim of the study is to establish if
           patients with advanced breast cancer in Meir Oncology Institute would follow homeopathic
           protocol as used by Dr Banerji in India, for six months. The secondary aim is to observe
           the quality of life and wellbeing of patients undergoing this protocol.

        -  Patients with the diagnosis of advanced breast cancer who attend the Meir Oncology
           Institute clinic will be offered by their treating physician or nurse a fact sheet about
           this study and will be asked to participate in this protocol. The protocol will be
           explained to the patient by the research team. If they agree to participate they will be
           given a consent form to sign, and basic information will be obtained from each patient.
           This information will include basic demographics (age, marital status, employment ,
           education level) and basic medical information ( Disease status and progress, current
           symptoms, medications and treatments being used, complementary medicine being used) as
           well as evaluation of quality of life using the European Organization for Research and
           Treatment of Cancer (EORTC) quality of life questionnaire (QLQ).

        -  Patients will receive the selected homeopathic remedies (Carcinosin 30C, Phytolacca
           200C, and Thuja 30C) with written instructions about the proper use of the remedies. The
           remedies will be offered to patients in addition to their regular conventional care.
           Patients that cannot participate in conventional cancer care due to side effects,
           expected adverse reactions or other reasons that prevent them from utilizing
           conventional care will be offered to participate in the study, as well. In addition,
           patients who for their own reasons elect to refuse conventional treatment can be offered
           to participate in the study in order to keep them in the system and not lose them to
           alternative untested treatments. Every 4 weeks for the period of 3 months and once at 6
           months, a research assistant/ research nurse will contact each participant to review
           EORTC QLQ- C-30 questionnaire to evaluate quality of life as well as a follow up
           questionnaire which will verify the actual use of these remedies, perceived problems in
           taking these remedies, utilization of other therapies, address patients concerns, and
           document disease progression. A total of 30 patients will be enrolled in this study and
           their data will be reviewed and analyzed six months after recruitment to the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: To establish if patients with advanced breast cancer in Meir Oncology Institute would follow a homeopathic treatment protocol as used by Dr Banerji in India, for six months.
time frame: Six months
description: Investigators will follow patients with advanced breast cancer in Meir Oncology Institute and see if patients would follow a homeopathic treatment protocol as used by Dr Banerji in India, for six months.
measure: Observe and verify the quality of life and wellbeing of patients undergoing this protocol
time frame: Six months
description: Investigators will document the quality of life and wellbeing of patients undergoing this protocol utilizing the EORTC QLQ-C30 (a questionnaire developed to assess the quality of life of cancer patients).
arm group label: Homeopathic treatment
arm group type: Experimental
description: A feasibility study examining whether patients with advanced breast cancer would follow a homeopathic protocol for three to six months.
intervention type: Other
intervention name: Homeopathic treatment
description: Remedies are sold over the counter without a physician prescription (approved by the Israeli Ministry of Health). No toxicity or side effects are expected to be observed, potencies (dilutions) of substances beyond 7C (7 dilutions, each 1:100) do not contain a sufficient number of molecules of the original material to be pharmacologically active. Since the remedies being used in this trial are diluted at 30c and 200c, levels that are way beyond Avogrado's number, so no original material is expected to be found. This fact was verified utilizing high pressure liquid chromatography (HPLC) method. Due to those facts, most scientists do not accept that these remedies have any biological effects and consign any positive response to the placebo effect.
arm group label: Homeopathic treatment
other name: A combined treatment of three homeopathic remedies:
other name: Phytolacca 200C
other name: Thuja 30C
other name: Carcinosin 30c
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Moshe Frenkel, MD
role: Principal Investigator
affiliation: Institute of Oncology Meir Medical Center
facility: 
country: Israel
url: http://www.moshefrenkelmd.com/index.asp?page=2171&lang=eng
description: Integrative Oncology - Homeopathy
citation: Frenkel M, Mishra BM, Sen S, Yang P, Pawlus A, Vence L, Leblanc A, Cohen L, Banerji P, Banerji P. Cytotoxic effects of ultra-diluted remedies on breast cancer cells. Int J Oncol. 2010 Feb;36(2):395-403.
PMID: 20043074
responsible party type: Principal Investigator
investigator affiliation: Meir Medical Center
investigator full name: Moshe Frenkel
investigator title: MD
mesh term: Breast Neoplasms
sharing ipd: Yes
ipd description: Publications, Presentations in international meetings