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A Study of PRP Treatment for Hair Loss After Cancer Therapy in Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT04459650
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alopecia Procedure: Platelet Rich Plasma system Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Female Breast Cancer Pts
Participants include female breast cancer patients who either receive endocrine therapy and suffer from endocrine induced alopecia or suffer from post chemotherapy induced alopecia.
Procedure: Platelet Rich Plasma system
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).
Other Name: PRP




Primary Outcome Measures :
  1. Hair Density [ Time Frame: 12 weeks from baseline ]
    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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women ≥ 18 years of age
  • Have a clinical diagnosis of endocrine therapy induced alopecia (EIA) for breast cancer:

    • Selective estrogen receptor modulators (tamoxifen, toremifene)
    • Aromatase inhibitors (anastrozole, letrozole, exemestane)
    • Gonadotropin-releasing hormone agonist (leuprolide)

OR

  • Must have a clinical diagnosis of chemotherapy induced (pCIA) alopecia with incomplete or absent regrowth of hair > 3 months after completion of chemotherapy without use of endocrine cancer-related therapy (ET) within the last 6 months
  • Ludwig stage 1-3 for women
  • If patient has a history of use of topical minoxidil and/or systemic spironolactone for alopecia for at least three consecutive months, then a 3 month washout is required prior to start of treatment
  • Completed informed consent form

Exclusion Criteria:

  • Patients who are pregnant or breastfeeding
  • History of hair transplantation
  • Use of any cosmetic product aimed at improving or correcting the signs of hair loss within 2weeks prior to screening. Note: patients are not permitted to use any hair loss products during the study.
  • An active scalp dermatologic condition (e.g. alopecia areata, scalp psoriasis), scalp skin cancer (e.g. BCC, SCC), a pre-existing condition with sequelae on the scalp (e.g. scarring alopecia) or acute infection.
  • Hereditary or acquired hematologic/coagulation disorders such as: platelet dysfunction syndrome, critical thrombocytopenia (platelet count <150,000 platelets/ul),hypofibrinogenemia, impaired coagulation, drepanocytosis (sickle cell anemia).
  • Actively receiving anticoagulant medication
  • Patients taking Aspirin or other NSAIDs such as Nurofen, Voltaren, Diclofenac or Naproxen, or fish-oil supplements because of its anti-platelet activity, can participate, provided medication is interrupted 7 days before beginning of the treatment.
  • Planned or previous radiation therapy to the brain
  • Vulnerable populations e.g. decisionally impaired (cognitive, psychiatric) or patients who, in the opinion of the investigator have a condition that precludes their ability to provide an informed consent
  • Patients taking hair supplements, such as biotin or biosil, can participate, provided hair supplements are washed out 3 months prior to beginning of treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459650


Contacts
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Contact: Anthony M Rossi, MD 646-608-2311 rossia@mskcc.org
Contact: Mario E Lacouture, MD 646-608-2337 LacoutuM@mskcc.org

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Anthony Rossi, MD    646-608-2311      
Contact: Mario Lacouture, MD    646-608-2337      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Anthony M Rossi, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04459650    
Other Study ID Numbers: 20-133
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: May 12, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
endocrine therapy induced alopecia
EIA
chemotherapy induced alopecia
pCIA
Memorial Sloan Kettering Cancer Center
20-133
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical