Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT04459650

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York New York, 10065, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Early Phase 1

Estimated Enrollment:

30

Study ID:

NCT04459650

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

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