Status:
COMPLETED
A Study of PRP Treatment for Hair Loss After Cancer Therapy in Women With Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Alopecia
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
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 injec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04459650
Start Date
June 23 2020
End Date
August 14 2025
Last Update
August 17 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065