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
|Condition or disease||Intervention/treatment||Phase|
|Alopecia||Procedure: Platelet Rich Plasma system||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
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
|Contact: Anthony M Rossi, MDfirstname.lastname@example.org|
|Contact: Mario E Lacouture, MD||646-608-2337||LacoutuM@mskcc.org|
|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|
|Principal Investigator:||Anthony M Rossi, MD||Memorial Sloan Kettering Cancer Center|