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

Alopecia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04459650
• Other study ID #: 20-133
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: June 23, 2020
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata

Intervention

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).

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hair Density	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.	12 weeks from baseline

External Links

•   Memorial Sloan Kettering Cancer Center