<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/NCT01662076</url>
  </required_header>
  <id_info>
    <org_study_id>1000027444</org_study_id>
    <nct_id>NCT01662076</nct_id>
  </id_info>
  <brief_title>Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy</brief_title>
  <official_title>A Feasibility Pilot Trial of Individualized Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cancer-related fatigue has been described as a subjective feeling of physical, emotional,&#xD;
      and/or cognitive tiredness. Fatigue is frequently identified as one of the most troublesome&#xD;
      symptoms in pediatric cancer patients. Fatigue affects children with cancer throughout the&#xD;
      trajectory of their disease. Treatment interventions for cancer-related fatigue have been&#xD;
      largely unsuccessful. Homeopathy involves treatment of patients with diluted natural&#xD;
      substances aimed at stimulating the body's healing system. In the efficacy trial literature,&#xD;
      individualized homeopathy shows the most promise over other forms of homeopathic&#xD;
      intervention. Individualized homeopathic treatment involves a unique yet established method&#xD;
      of case taking. During the consultation, the homeopath asks a series of broad questions to&#xD;
      elicit subjective symptoms related to the patient's disease, their medical history, as well&#xD;
      as particular characteristics (physical or psychological) related to the individual. This&#xD;
      study will recruit children receiving chemotherapy to undergo homeopathic remedies to treat&#xD;
      their fatigue. This study hypothesizes that homeopathic treatment will effectively treat&#xD;
      fatigue.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 3</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of recruitment</measure>
    <time_frame>baseline</time_frame>
    <description>The primary objective is to determine the feasibility of recruiting patients for a study of individualized homeopathy in paediatric patients receiving chemotherapy for cancer.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of administration</measure>
    <time_frame>14 days</time_frame>
    <description>To determine the feasibility of administering individualized homeopathy in pediatric cancer patients receiving chemotherapy for cancer by describing the proportion of participants who complete at least 10 days of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fatigue</measure>
    <time_frame>Change from baseline to 14 days</time_frame>
    <description>To describe changes in fatigue scores according to the Symptom Distress Scale (SDS) and the PedsQL Multidimension Fatigue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life</measure>
    <time_frame>Change from baseline to 14 days</time_frame>
    <description>To describe changes in generic and cancer specific quality of life as measured by the PedsQL Generic Core Scales and Acute Cancer Module</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Sublingual or Oral Liquid Homeopathy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The homeopathic remedy will be administered as 1 lactose/sucrose globule 2.5 mm in diameter to be administered sublingually up to 3 times per day or as 0.2 ml of a 30% ethanol based liquid homeopathic remedy administered orally up to 3 times per day. The homeopathic remedy and/or the homeopathic remedy potency can be changed on a daily basis during the course of treatment. However, only one homeopathic remedy and potency will be administered at a given time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Homeopathic Remedies</intervention_name>
    <description>The homeopathic remedy will be administered as either 1 globule sublingual or 0.2 mL oral (depending on chosen formulation) up to 3 times per day. The homeopath will decide which formulation will be used. Homeopathic remedies prepared according to the standards as set out by Health Canada. The caregiver or patient will be asked to administer the homeopathic remedy at least 30 minutes before or after taking other medications, food and strong smelling substances (such as camphor, mint, or coffee).</description>
    <arm_group_label>Sublingual or Oral Liquid Homeopathy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with any type of cancer. Patients may have newly diagnosed, relapsed or a&#xD;
             second malignant disease.&#xD;
&#xD;
          -  Receiving any type of chemotherapy administered intermittently (i.e. not continuous&#xD;
             administration) with or without radiation treatment&#xD;
&#xD;
          -  Discharge from SickKids is anticipated to occur following completion of the current&#xD;
             inpatient chemotherapy or chemotherapy is being administered as an outpatient&#xD;
&#xD;
          -  Between 2 and 18 years of age (age range for which instruments are available and&#xD;
             children may be able to comply with homeopathy) A score on the Symptoms Distress Scale&#xD;
             (SDS) of 2 or higher&#xD;
&#xD;
          -  Able to ingest medications in lactose/sucrose globule or liquid form&#xD;
&#xD;
          -  Reside within Greater Toronto area or willing to travel to the Riverdale Homeopathic&#xD;
             Clinic. Participants living outside of the Greater Toronto area who wish to receive&#xD;
             home visits may be eligible provided that permission is granted by the homeopath&#xD;
             investigator&#xD;
&#xD;
          -  A parent or caregiver must be able to read and write in English.&#xD;
&#xD;
          -  Patients who are currently receiving CAM including homeopathy are eligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of allergy to the homeopathic products&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lillian Sung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>May 19, 2015</last_update_submitted>
  <last_update_submitted_qc>May 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Lillian Sung</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Fatigue</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Pediatrics</keyword>
  <keyword>Homeopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue</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/NCT01662076
org study id: 1000027444
nct id: NCT01662076
lead sponsor: 
has dmc: No
Cancer-related fatigue has been described as a subjective feeling of physical, emotional,
      and/or cognitive tiredness. Fatigue is frequently identified as one of the most troublesome
      symptoms in pediatric cancer patients. Fatigue affects children with cancer throughout the
      trajectory of their disease. Treatment interventions for cancer-related fatigue have been
      largely unsuccessful. Homeopathy involves treatment of patients with diluted natural
      substances aimed at stimulating the body's healing system. In the efficacy trial literature,
      individualized homeopathy shows the most promise over other forms of homeopathic
      intervention. Individualized homeopathic treatment involves a unique yet established method
      of case taking. During the consultation, the homeopath asks a series of broad questions to
      elicit subjective symptoms related to the patient's disease, their medical history, as well
      as particular characteristics (physical or psychological) related to the individual. This
      study will recruit children receiving chemotherapy to undergo homeopathic remedies to treat
      their fatigue. This study hypothesizes that homeopathic treatment will effectively treat
      fatigue.
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: Feasibility of recruitment
time frame: baseline
description: The primary objective is to determine the feasibility of recruiting patients for a study of individualized homeopathy in paediatric patients receiving chemotherapy for cancer.
measure: Feasibility of administration
time frame: 14 days
description: To determine the feasibility of administering individualized homeopathy in pediatric cancer patients receiving chemotherapy for cancer by describing the proportion of participants who complete at least 10 days of treatment
measure: Changes in fatigue
time frame: Change from baseline to 14 days
description: To describe changes in fatigue scores according to the Symptom Distress Scale (SDS) and the PedsQL Multidimension Fatigue Scale
measure: Changes in quality of life
time frame: Change from baseline to 14 days
description: To describe changes in generic and cancer specific quality of life as measured by the PedsQL Generic Core Scales and Acute Cancer Module
arm group label: Sublingual or Oral Liquid Homeopathy
arm group type: Experimental
description: The homeopathic remedy will be administered as 1 lactose/sucrose globule 2.5 mm in diameter to be administered sublingually up to 3 times per day or as 0.2 ml of a 30% ethanol based liquid homeopathic remedy administered orally up to 3 times per day. The homeopathic remedy and/or the homeopathic remedy potency can be changed on a daily basis during the course of treatment. However, only one homeopathic remedy and potency will be administered at a given time.
intervention type: Other
intervention name: Homeopathic Remedies
description: The homeopathic remedy will be administered as either 1 globule sublingual or 0.2 mL oral (depending on chosen formulation) up to 3 times per day. The homeopath will decide which formulation will be used. Homeopathic remedies prepared according to the standards as set out by Health Canada. The caregiver or patient will be asked to administer the homeopathic remedy at least 30 minutes before or after taking other medications, food and strong smelling substances (such as camphor, mint, or coffee).
arm group label: Sublingual or Oral Liquid Homeopathy
criteria: 
gender: All
minimum age: 2 Years
maximum age: 18 Years
healthy volunteers: No
last name: Lillian Sung, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Lillian Sung
investigator title: Staff Physician
mesh term: Fatigue