<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/NCT04459650</url>
  </required_header>
  <id_info>
    <org_study_id>20-133</org_study_id>
    <nct_id>NCT04459650</nct_id>
  </id_info>
  <brief_title>A Study of PRP Treatment for Hair Loss After Cancer Therapy in Women With Breast Cancer</brief_title>
  <official_title>A Pilot Study of the Clinical Effectiveness of Platelet-Rich Plasma (PRP) for the Treatment of Endocrine Therapy-Induced Alopecia (EIA) and Permanent Chemotherapy-Induced Alopecia (pCIA) in Breast Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants who enroll in this study will undergo the platelet-rich plasma (PRP) study&#xD;
      treatment. Participants will have a sample of blood collected and the platelets will be&#xD;
      separated and then injected into half of the participants' scalp every 4 weeks for 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 23, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>Early Phase 1</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hair Density</measure>
    <time_frame>12 weeks from baseline</time_frame>
    <description>The primary endpoint of this study is the is the relative density in scalp hair at week 12compared to baseline (week 0) between treatment and observation sides of the scalp. The study investigator will use the 7-point GAS (-3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, and +3 = greatly increased) to evaluate relative differences in hair density.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Alopecia</condition>
  <arm_group>
    <arm_group_label>Female Breast Cancer Pts</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants include female breast cancer patients who either receive endocrine therapy and suffer from endocrine induced alopecia or suffer from post chemotherapy induced alopecia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Platelet Rich Plasma system</intervention_name>
    <description>Participants will receive PRP obtained with PRP harvesting kits on one side of the scalp and no injections on the other side of the scalp (split-scalp technique). The entire half of the intended scalp will receive inter-follicular injections of PRP under aseptic conditions at the amount of 0.05-0.1 ml/cm2 in a retrograde fashion from deep to superficial, at every centimeter throughout the treated site. For study purposes, Study Day 0 is defined as the first day of injection. Subsequently the patient will continue therapy every 4 weeks for a total of 3 injections (12 weeks).</description>
    <arm_group_label>Female Breast Cancer Pts</arm_group_label>
    <other_name>PRP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women ≥ 18 years of age&#xD;
&#xD;
          -  Have a clinical diagnosis of endocrine therapy induced alopecia (EIA) for breast&#xD;
             cancer:&#xD;
&#xD;
               -  Selective estrogen receptor modulators (tamoxifen, toremifene)&#xD;
&#xD;
               -  Aromatase inhibitors (anastrozole, letrozole, exemestane)&#xD;
&#xD;
               -  Gonadotropin-releasing hormone agonist (leuprolide)&#xD;
&#xD;
        OR&#xD;
&#xD;
          -  Must have a clinical diagnosis of chemotherapy induced (pCIA) alopecia with incomplete&#xD;
             or absent regrowth of hair &gt; 3 months after completion of chemotherapy without use of&#xD;
             endocrine cancer-related therapy (ET) within the last 6 months&#xD;
&#xD;
          -  Ludwig stage 1-3 for women&#xD;
&#xD;
          -  If patient has a history of use of topical minoxidil and/or systemic spironolactone&#xD;
             for alopecia for at least three consecutive months, then a 3 month washout is required&#xD;
             prior to start of treatment&#xD;
&#xD;
          -  Completed informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are pregnant or breastfeeding&#xD;
&#xD;
          -  History of hair transplantation&#xD;
&#xD;
          -  Use of any cosmetic product aimed at improving or correcting the signs of hair loss&#xD;
             within 2weeks prior to screening. Note: patients are not permitted to use any hair&#xD;
             loss products during the study.&#xD;
&#xD;
          -  An active scalp dermatologic condition (e.g. alopecia areata, scalp psoriasis), scalp&#xD;
             skin cancer (e.g. BCC, SCC), a pre-existing condition with sequelae on the scalp (e.g.&#xD;
             scarring alopecia) or acute infection.&#xD;
&#xD;
          -  Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction&#xD;
             syndrome, critical thrombocytopenia (platelet count &lt;150,000&#xD;
             platelets/ul),hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell&#xD;
             anemia).&#xD;
&#xD;
          -  Actively receiving anticoagulant medication&#xD;
&#xD;
          -  Patients taking Aspirin or other NSAIDs such as Nurofen, Voltaren, Diclofenac or&#xD;
             Naproxen, or fish-oil supplements because of its anti-platelet activity, can&#xD;
             participate, provided medication is interrupted 7 days before beginning of the&#xD;
             treatment.&#xD;
&#xD;
          -  Planned or previous radiation therapy to the brain&#xD;
&#xD;
          -  Vulnerable populations e.g. decisionally impaired (cognitive, psychiatric) or patients&#xD;
             who, in the opinion of the investigator have a condition that precludes their ability&#xD;
             to provide an informed consent&#xD;
&#xD;
          -  Patients taking hair supplements, such as biotin or biosil, can participate, provided&#xD;
             hair supplements are washed out 3 months prior to beginning of treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony M Rossi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>endocrine therapy induced alopecia</keyword>
  <keyword>EIA</keyword>
  <keyword>chemotherapy induced alopecia</keyword>
  <keyword>pCIA</keyword>
  <keyword>Memorial Sloan Kettering Cancer Center</keyword>
  <keyword>20-133</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</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/NCT04459650
org study id: 20-133
nct id: NCT04459650
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Participants who enroll in this study will undergo the platelet-rich plasma (PRP) study
      treatment. Participants will have a sample of blood collected and the platelets will be
      separated and then injected into half of the participants' scalp every 4 weeks for 12 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hair Density
time frame: 12 weeks from baseline
description: The primary endpoint of this study is the is the relative density in scalp hair at week 12compared to baseline (week 0) between treatment and observation sides of the scalp. The study investigator will use the 7-point GAS (-3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, and +3 = greatly increased) to evaluate relative differences in hair density.
arm group label: Female Breast Cancer Pts
arm group type: Experimental
description: Participants include female breast cancer patients who either receive endocrine therapy and suffer from endocrine induced alopecia or suffer from post chemotherapy induced alopecia.
intervention type: Procedure
intervention name: Platelet Rich Plasma system
description: Participants will receive PRP obtained with PRP harvesting kits on one side of the scalp and no injections on the other side of the scalp (split-scalp technique). The entire half of the intended scalp will receive inter-follicular injections of PRP under aseptic conditions at the amount of 0.05-0.1 ml/cm2 in a retrograde fashion from deep to superficial, at every centimeter throughout the treated site. For study purposes, Study Day 0 is defined as the first day of injection. Subsequently the patient will continue therapy every 4 weeks for a total of 3 injections (12 weeks).
arm group label: Female Breast Cancer Pts
other name: PRP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anthony M Rossi, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
country: United States
url: http://www.mskcc.org
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Alopecia
mesh term: Alopecia Areata
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.