This trial investigates how well platelet-rich plasma works in treating endocrine therapy-induced alopecia or permanent chemotherapy-induced alopecia (hair loss) in patients with breast cancer. Platelet-rich plasma is a product made from a patient's own blood cells. It may promote natural hair growth and maintain the new growth by increasing the supply of growth factors to their hair follicles (roots). Growth factors are substances made by the body that function to regulate cell division and cell survival. Injecting platelet-rich plasma into the scalp may help hair grow back or become thicker in patients with alopecia.
Additional locations may be listed on ClinicalTrials.gov for NCT04459650.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess the therapeutic efficacy of platelet-rich plasma (PRP) injections when compared to untreated scalp in treating endocrine therapy-induced alopecia (EIA) and permanent chemotherapy-induced alopecia (pCIA) when injected into the scalp once every 4 weeks over a course of 12 weeks, which will be determined by investigator assessment on changes in hair growth/scalp coverage using the 7-point global assessment scale (GAS), when compared to baseline.
SECONDARY OBJECTIVES:
I. To assess the efficacy of PRP injections on EIA and pCIA by changes in hair count/shaft diameter in standardized trichoscopic imaging as assessed by blinded investigators.
II. To assess the quality of life effect of PRP injections on EIA and pCIA by change in the Hairdex quality of life (QoL) questionnaire score as reported by the patient.
III. To assess family history of all patients for androgenic alopecia (AGA) and correlate to occurrence of pCIA or EIA.
IV. To assess serum levels of TSH, fT4, vitamin D3, zinc, ferritin, total testosterone (TT), dihydrotestosterone (DHT), sex hormone binding globulin (SHBG), luteinizing hormone (LH), follicle-stimulating hormone (FSH), vitamin A, vitamin C, folic acid, vitamin B3, vitamin B6, vitamin B12, copper, iron, and total iron binding capacity (TIBC) at baseline and after 24 weeks.
V. To assess the tolerability and safety of PRP injections in this cohort of patients by patient and investigator reported adverse events.
OUTLINE:
Breast cancer patients with endocrine induced alopecia as well as breast cancer patients with permanent chemotherapy induced alopecia receive PRP via injection over one half of their scalp every 4 weeks for a total of 3 injections (12 weeks) in the absence of disease progression or unacceptable toxicity.
After completion of initial study treatment, patients are followed up for 3 months, at this time patients who benefited from treatment may be treated in the other (untreated) half of their scalp.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorAnthony Rossi
