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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Active, not recruiting; Early Phase 1

Conditions: Alopecia

Treatments: Procedure: Platelet Rich Plasma system

Study type: Interventional

Funder types: Other

Identifiers

NCT04459650

20-133

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Female Breast Cancer Pts

Experimental group

Description:

Participants include female breast cancer patients who either receive endocrine therapy and suffer from endocrine induced alopecia or suffer from post chemotherapy induced alopecia.

Treatment:

Procedure: Platelet Rich Plasma system