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

NCT ID: NCT04459650

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-23
• Study Completion Date: 2025-08-14

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.

Conditions

Alopecia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Platelet Rich Plasma system

Intervention Type: PROCEDURE

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).

Interventions

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).

Intervention Type: PROCEDURE

Other Intervention Names

PRP

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony M Rossi, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Countries

United States

References

Rossi A, Pan A, Menzer C, Lavin L, Aleissa S, Aleisa A, Alshaikh H, Dranitsaris G, Dusza S, Bravo C, Lacouture ME. Platelet-Rich Plasma Treatment for Endocrine-Induced Alopecia and Persistent Chemotherapy-Induced Alopecia in Breast Cancer Survivors: A Randomized, Controlled, Pilot Study. Dermatol Surg. 2025 Jul 8. doi: 10.1097/DSS.0000000000004755. Online ahead of print.

Reference Type: DERIVED

PMID: 40626588 (View on PubMed)

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

20-133

Identifier Type: -

Identifier Source: org_study_id