Alopecia
Conditions
Keywords
endocrine therapy induced alopecia, EIA, chemotherapy induced alopecia, pCIA, Memorial Sloan Kettering Cancer Center, 20-133
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.
Interventions
PROCEDUREPlatelet 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).
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hair Density | 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. |
Countries
United States
Outcome results
None listed