Clinical trial NCT04459650: A Study of PRP Treatment for Hair Loss After Cancer Therapy in Women With Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Alopecia
Keywords: endocrine therapy induced alopecia
EIA
chemotherapy induced alopecia
pCIA
Memorial Sloan Kettering Cancer Center
20-133
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Hair Density
timeFrame: 12 weeks from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Anthony M Rossi, MD
role: PRINCIPAL_INVESTIGATOR
References: