<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/NCT02986412</url>
  </required_header>
  <id_info>
    <org_study_id>VOLUME2</org_study_id>
    <nct_id>NCT02986412</nct_id>
  </id_info>
  <brief_title>A 6-month Post-interventional Follow-up Extension of VOLUME Study (VOLUME-2)</brief_title>
  <acronym>VOLUME2</acronym>
  <official_title>Evaluation of the Impact of a Topical Lotion, CG428, on Permanent Chemotherapy Induced Hair and Scalp Disorders in Cancer Survivors: An Open-label 6 Months Extension of VOLUME Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Legacy Healthcare Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We would suggest to conduct &quot;VOLUME-2&quot; study, as an extension of the ongoing &quot;VOLUME&quot; study&#xD;
      with all subjects already included. After completion of VOLUME study, the study will be&#xD;
      directly extend with an &quot;open-label design&quot;. All participants, who agreed to pursue, with&#xD;
      either &quot;Placebo&quot; or &quot;CG428&quot;, will receive CG428 treatment for an additional six-month period.&#xD;
      VOLUME-2 study would be ideal and timely by enabling no interruption of product use.&#xD;
&#xD;
      The Primary Objective is to observe for a longer period the efficacy of CG428 (12 months :&#xD;
      6months Volume + 6 months Volume-2) in order to better discriminate later or non-responder&#xD;
      populations.&#xD;
&#xD;
      Secondary Objectives are :&#xD;
&#xD;
        -  Evaluate how far CG428 can improve hair-pattern (reach a plateau or constant&#xD;
           progression)&#xD;
&#xD;
        -  Evaluate motivation and adherence of subjects&#xD;
&#xD;
        -  Long term safety&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research team at Cancer Education Center at Samsung Comprehensive Cancer Center has&#xD;
      studied CIA and its impact on distress and psychosocial well-being since 2008. We found that&#xD;
      more than half of the breast cancer patients experienced higher distress due to CIA, during&#xD;
      cancer treatment, and this distress was strongly associated with negative body image, overall&#xD;
      health status, and psychosocial well-being. In a recent prospective cohort study, we assessed&#xD;
      skin and hair change patterns before, during and 6 months after chemotherapy in 61&#xD;
      volunteers.&#xD;
&#xD;
      We found that the majority of the patients still experienced CIA at 6 months after completion&#xD;
      of chemotherapy. Actually, hair diameter at 6th month after chemotherapy had not recovered to&#xD;
      baseline level. Permanent chemotherapy-induced alopecia, defined as absent or incomplete hair&#xD;
      regrowth at ≥6 months post-chemotherapy, was reported from 53 to 74%. Like CIA, permanent CIA&#xD;
      also lacks recognition and has been underserved regardless of patients' needs. The first&#xD;
      botanical blend Legacy Healthcare developed and patented is Cellium. Cellium is composed of 4&#xD;
      botanicals (Allium cepa L., Citrus limon L., Theobroma cacao L., Paullinia cupana).&#xD;
&#xD;
      The first product derived from Cellium is a topical lotion for male and female alopecia,&#xD;
      CG210. Based on the safety and efficacy data, the EMA (European Medicines Agency) has&#xD;
      considered CG210 eligible for a European centralized herbal medicine registration. CG428 is&#xD;
      the second product derived from Cellium. CG428 contains the exact same ingredients as CG210,&#xD;
      in a different dosage. Legacy Healthcare have conducted a pilot studies with CG428 in Japan.&#xD;
      The trial included female cancer survivors experiencing permanent/persistent CIA for more&#xD;
      than 12.&#xD;
&#xD;
      Based on the results, several cancer treatment centers in Japan have started to recommend the&#xD;
      product on a compassionate basis.We therefore hypothesize that the investigated topical&#xD;
      lotion may mitigate the impact of protracted or permanent CIA in cancer survivors by&#xD;
      restoring a normalized apoptotic process of hair follicular cells and reducing the acute, as&#xD;
      well as chronic inflammation in the scalp, two issues that may remain unsettled following&#xD;
      anticancer treatment. While considering the subjects included in the &quot;VOLUME&quot; study, it&#xD;
      appears that a majority of cancer survivors did not recover a full hair pattern even 3 years&#xD;
      after cancer treatment. This is per se an interesting data, and a new and significant&#xD;
      knowledge revealing that persistent chemotherapy induced apopecia (CIA) is more common than&#xD;
      anticipated.&#xD;
&#xD;
      While considering the subjects included in the &quot;VOLUME&quot; study, it appears that a majority of&#xD;
      cancer survivors did not recover a full hair pattern even 3 years after cancer treatment.&#xD;
      This is per se an interesting data, and a new and significant knowledge revealing that&#xD;
      persistent chemotherapy induced apopecia (CIA) is more common than anticipated.&#xD;
&#xD;
      The &quot;VOLUME&quot; study could have in fact two major repercussions: in addition to give&#xD;
      information on CG428 efficacy, it will help to better define persistent CIA and improve&#xD;
      thereby our scientific knowledge of this condition. Considering the high prevalence and poor&#xD;
      literature on persistent CIA, it appears important to study this condition further.&#xD;
&#xD;
      To this end, we would suggest to conduct &quot;VOLUME-2&quot; study, as an extension of the ongoing&#xD;
      &quot;VOLUME&quot; study with all subjects already included.&#xD;
&#xD;
      This study aims to evaluation of Longer observation (12 months : 6months Volume + 6 months&#xD;
      Volume-2) permitting to better discriminate later or non-responder populations.&#xD;
&#xD;
      This is a open-label, single center, observation study in breast cancer survivors of VOLUME&#xD;
      participants.&#xD;
&#xD;
      Hair condition and parameters of 31 breast cancer survivors who were previously included in&#xD;
      VOLUME study (a randomized controlled trial to evaluate effect of CG428 which is topical hair&#xD;
      lotion for chemotherapy induced alopecia completed in December, 2016) will be assessed.&#xD;
&#xD;
      The participation du extension Volume-2 study will be proposed to patients during the last&#xD;
      visit of Volume study (Month 6)&#xD;
&#xD;
      The &quot;VOLUME&quot; study could have in fact two major repercussions: in addition to give&#xD;
      information on CG428 efficacy, it will help to better define persistent CIA and improve&#xD;
      thereby our scientific knowledge of this condition. Considering the high prevalence and poor&#xD;
      literature on persistent CIA, it appears important to study this condition further.&#xD;
&#xD;
      To this end, we would suggest to conduct &quot;VOLUME-2&quot; study, as an extension of the ongoing&#xD;
      &quot;VOLUME&quot; study with all subjects already included.&#xD;
&#xD;
      This study aims to evaluation of Longer observation (12 months : 6months Volume + 6 months&#xD;
      Volume-2) permitting to better discriminate later or non-responder populations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2016</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2016</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>Hair thickness</measure>
    <time_frame>6 months after intervention</time_frame>
    <description>Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chemotherapy-induced alopecia distress Stress Using Chemotherapy induced</measure>
    <time_frame>All time (baseline, 3month and 6 months after intervention)</time_frame>
    <description>Respondents will be instructed to indicate on a 4-point Likert scale on each</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global photographs</measure>
    <time_frame>All time (baseline, 3month and 6 months after intervention)</time_frame>
    <description>Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject using Canon EOS 70D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall hair and scalp condition</measure>
    <time_frame>All time (baseline, 3month and 6 months after intervention)</time_frame>
    <description>Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nail condition</measure>
    <time_frame>All time (baseline, 3month and 6 months after intervention)</time_frame>
    <description>Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life at the time</measure>
    <time_frame>All time (baseline, 3month and 6 months after intervention)</time_frame>
    <description>European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 and breast specific module</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with products</measure>
    <time_frame>All time (baseline, 3month and 6 months after intervention)</time_frame>
    <description>We will use self-reported questionnaire for satisfaction with the products as well as suggestions for improvement after completion of study with patients who received the CG428.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willing to Pay</measure>
    <time_frame>6 months after intervention</time_frame>
    <description>We will ask how much to willing to pay for CG428</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hair condition</measure>
    <time_frame>All time (baseline, 3month and 6 months after intervention)</time_frame>
    <description>Outcomes will be collected using objective methods and patient reported outcomes:&#xD;
Objectively quantified: Hair thickness and density: We will measure hair thickness and density using Folliscope 4.0, LeadM We will take a picture on the parietal (To around 2 cm) and then analysis using Folliscope program.&#xD;
Global photographs: Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Group in VOLUME</measure>
    <time_frame>At baseline</time_frame>
    <description>Information about what group they belonged to in previous studies</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Alopecia</condition>
  <condition>Chemotherapy Effects</condition>
  <arm_group>
    <arm_group_label>CG428</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will self-administer the study product twice per day (morning, evening) for 6 months, for the efficacy assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CG428</intervention_name>
    <description>The experimental group will receive CG428. For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp. Hairs should not be washed or shampooed within 1 hour following study treatment administration. Each dose should be spaced out by minimum 4 hours.</description>
    <arm_group_label>CG428</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hair parameters obtained before the start of chemotherapy&#xD;
&#xD;
          -  Patients who participated in VOLUME&#xD;
&#xD;
          -  Able to keep their hair style&#xD;
&#xD;
          -  Able to use the study treatment in compliance with the protocol.&#xD;
&#xD;
          -  Physical (ECOG≤1) and psychological ability to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant use of other anti-hair-loss treatment or hair growth treatment.&#xD;
&#xD;
          -  Patients with recent hair transplants or who plan to have transplants.&#xD;
&#xD;
          -  Known allergy or hypersensitivity to some components of CG428 (including allium cepa&#xD;
             (onion), citrus, caffeine, theobromine)&#xD;
&#xD;
          -  Pre-existing alopecia or significant scalp disease, which may alter study treatment&#xD;
             administration or absorption.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juhee Cho, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Danbee Kang</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.gov/ct2/show/NCT02605629?term=juhee+cho&amp;rank=1</url>
    <description>EValuation of the Impact of a TOpical Lotion on Permanent Chemotherapy Induced Hair Disorders in Cancer Survivors (VOLUME)</description>
  </link>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>August 30, 2018</last_update_submitted>
  <last_update_submitted_qc>August 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Juhee Cho</investigator_full_name>
    <investigator_title>Chair, Assistant Professor Department of Clinical Research Design &amp; Evaluation, SAIHST</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02986412
org study id: VOLUME2
nct id: NCT02986412
lead sponsor: 
collaborator: 
has dmc: No
We would suggest to conduct "VOLUME-2" study, as an extension of the ongoing "VOLUME" study
      with all subjects already included. After completion of VOLUME study, the study will be
      directly extend with an "open-label design". All participants, who agreed to pursue, with
      either "Placebo" or "CG428", will receive CG428 treatment for an additional six-month period.
      VOLUME-2 study would be ideal and timely by enabling no interruption of product use.

      The Primary Objective is to observe for a longer period the efficacy of CG428 (12 months :
      6months Volume + 6 months Volume-2) in order to better discriminate later or non-responder
      populations.

      Secondary Objectives are :

        -  Evaluate how far CG428 can improve hair-pattern (reach a plateau or constant
           progression)

        -  Evaluate motivation and adherence of subjects

        -  Long term safety
The research team at Cancer Education Center at Samsung Comprehensive Cancer Center has
      studied CIA and its impact on distress and psychosocial well-being since 2008. We found that
      more than half of the breast cancer patients experienced higher distress due to CIA, during
      cancer treatment, and this distress was strongly associated with negative body image, overall
      health status, and psychosocial well-being. In a recent prospective cohort study, we assessed
      skin and hair change patterns before, during and 6 months after chemotherapy in 61
      volunteers.

      We found that the majority of the patients still experienced CIA at 6 months after completion
      of chemotherapy. Actually, hair diameter at 6th month after chemotherapy had not recovered to
      baseline level. Permanent chemotherapy-induced alopecia, defined as absent or incomplete hair
      regrowth at ≥6 months post-chemotherapy, was reported from 53 to 74%. Like CIA, permanent CIA
      also lacks recognition and has been underserved regardless of patients' needs. The first
      botanical blend Legacy Healthcare developed and patented is Cellium. Cellium is composed of 4
      botanicals (Allium cepa L., Citrus limon L., Theobroma cacao L., Paullinia cupana).

      The first product derived from Cellium is a topical lotion for male and female alopecia,
      CG210. Based on the safety and efficacy data, the EMA (European Medicines Agency) has
      considered CG210 eligible for a European centralized herbal medicine registration. CG428 is
      the second product derived from Cellium. CG428 contains the exact same ingredients as CG210,
      in a different dosage. Legacy Healthcare have conducted a pilot studies with CG428 in Japan.
      The trial included female cancer survivors experiencing permanent/persistent CIA for more
      than 12.

      Based on the results, several cancer treatment centers in Japan have started to recommend the
      product on a compassionate basis.We therefore hypothesize that the investigated topical
      lotion may mitigate the impact of protracted or permanent CIA in cancer survivors by
      restoring a normalized apoptotic process of hair follicular cells and reducing the acute, as
      well as chronic inflammation in the scalp, two issues that may remain unsettled following
      anticancer treatment. While considering the subjects included in the "VOLUME" study, it
      appears that a majority of cancer survivors did not recover a full hair pattern even 3 years
      after cancer treatment. This is per se an interesting data, and a new and significant
      knowledge revealing that persistent chemotherapy induced apopecia (CIA) is more common than
      anticipated.

      While considering the subjects included in the "VOLUME" study, it appears that a majority of
      cancer survivors did not recover a full hair pattern even 3 years after cancer treatment.
      This is per se an interesting data, and a new and significant knowledge revealing that
      persistent chemotherapy induced apopecia (CIA) is more common than anticipated.

      The "VOLUME" study could have in fact two major repercussions: in addition to give
      information on CG428 efficacy, it will help to better define persistent CIA and improve
      thereby our scientific knowledge of this condition. Considering the high prevalence and poor
      literature on persistent CIA, it appears important to study this condition further.

      To this end, we would suggest to conduct "VOLUME-2" study, as an extension of the ongoing
      "VOLUME" study with all subjects already included.

      This study aims to evaluation of Longer observation (12 months : 6months Volume + 6 months
      Volume-2) permitting to better discriminate later or non-responder populations.

      This is a open-label, single center, observation study in breast cancer survivors of VOLUME
      participants.

      Hair condition and parameters of 31 breast cancer survivors who were previously included in
      VOLUME study (a randomized controlled trial to evaluate effect of CG428 which is topical hair
      lotion for chemotherapy induced alopecia completed in December, 2016) will be assessed.

      The participation du extension Volume-2 study will be proposed to patients during the last
      visit of Volume study (Month 6)

      The "VOLUME" study could have in fact two major repercussions: in addition to give
      information on CG428 efficacy, it will help to better define persistent CIA and improve
      thereby our scientific knowledge of this condition. Considering the high prevalence and poor
      literature on persistent CIA, it appears important to study this condition further.

      To this end, we would suggest to conduct "VOLUME-2" study, as an extension of the ongoing
      "VOLUME" study with all subjects already included.

      This study aims to evaluation of Longer observation (12 months : 6months Volume + 6 months
      Volume-2) permitting to better discriminate later or non-responder populations.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Hair thickness
time frame: 6 months after intervention
description: Objectively quantified hair thickness will measure using Folliscope 4.0, LeadM
measure: Chemotherapy-induced alopecia distress Stress Using Chemotherapy induced
time frame: All time (baseline, 3month and 6 months after intervention)
description: Respondents will be instructed to indicate on a 4-point Likert scale on each
measure: Global photographs
time frame: All time (baseline, 3month and 6 months after intervention)
description: Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject using Canon EOS 70D
measure: Overall hair and scalp condition
time frame: All time (baseline, 3month and 6 months after intervention)
description: Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.
measure: Nail condition
time frame: All time (baseline, 3month and 6 months after intervention)
description: Patient self-assessment: We will use self-reported questionnaire using visual analogue scale (VAS) ranging from 0 to 10.
measure: Quality of life at the time
time frame: All time (baseline, 3month and 6 months after intervention)
description: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 and breast specific module
measure: Satisfaction with products
time frame: All time (baseline, 3month and 6 months after intervention)
description: We will use self-reported questionnaire for satisfaction with the products as well as suggestions for improvement after completion of study with patients who received the CG428.
measure: Willing to Pay
time frame: 6 months after intervention
description: We will ask how much to willing to pay for CG428
measure: Hair condition
time frame: All time (baseline, 3month and 6 months after intervention)
description: Outcomes will be collected using objective methods and patient reported outcomes:
Objectively quantified: Hair thickness and density: We will measure hair thickness and density using Folliscope 4.0, LeadM We will take a picture on the parietal (To around 2 cm) and then analysis using Folliscope program.
Global photographs: Pictures to be focused on head/hair, which means shorter distance between the equipment and the subject
measure: Group in VOLUME
time frame: At baseline
description: Information about what group they belonged to in previous studies
arm group label: CG428
arm group type: Experimental
description: Patients will self-administer the study product twice per day (morning, evening) for 6 months, for the efficacy assessment
intervention type: Other
intervention name: CG428
description: The experimental group will receive CG428. For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp. Hairs should not be washed or shampooed within 1 hour following study treatment administration. Each dose should be spaced out by minimum 4 hours.
arm group label: CG428
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: No
last name: Juhee Cho, PhD
role: Principal Investigator
affiliation: Samsung Medical Center
facility: 
country: Korea, Republic of
url: https://clinicaltrials.gov/ct2/show/NCT02605629?term=juhee+cho&rank=1
description: EValuation of the Impact of a TOpical Lotion on Permanent Chemotherapy Induced Hair Disorders in Cancer Survivors (VOLUME)
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Juhee Cho
investigator title: Chair, Assistant Professor Department of Clinical Research Design & Evaluation, SAIHST
mesh term: Alopecia
sharing ipd: Undecided