Efficacy of Paxman Scalp Cooling to Prevent Chemo Induced Alopecia in Black Patients With Breast or GYN Cancers

Completed · Not applicable

Conditions studied: Breast Cancer, Ovarian Cancer, Gynecologic Neoplasm, Endometrial Cancer

In brief

This study will measure the efficacy of scalp cooling with the Paxman Scalp Cooling (PSC) device in a diverse patient population with success measured as prevention of more than 50% hair loss during chemotherapy. We propose that scalp cooling has distinct efficacy in participants with black or ethnic-minority hair types due to differences in textures, hair thickness. This study will examine the success rate of scalp cooling in black patients receiving chemotherapy for breast or gynecological cancer.

Key facts

Study ID

NCT04626895

Run by

Medstar Health Research Institute

People needed

15

Starts

2019-06-04

Expected to finish

2020-10-01

Last updated by the study team

2020-11-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Stage I-III breast cancer patients
• Stage I-III endometrial cancer patients
• Stage I-III ovarian cancer patients
• Self-identified as black: African, African-American, or Caribbean black are included . Patients of mixed race who identify as black are also included.
• Planned for >4 cycles of chemotherapy in the neoadjuvant or adjuvant setting with curative intent
• At least one chemotherapy agent being a taxane.
• Ability to read and answer questions in English
• Ability to sign informed consent for themselves.
• Able to fit into one of available cap sizes

You may not qualify if…

• Metastatic cancer patients
• Patients who do not self-identify as black (see definition above)
• History of cryoglobulinemia or cold agglutin disease
• Prior chemotherapy
• Non-taxane chemotherapy regimens (anthracycline based chemotherapy regimens are eligible for breast cancer patients)
• Baseline alopecia
• Concurrent medications to prevent hair loss
• Cold urticaria and cold- induced anaphylaxis
• Unable to fit into an available cap size
• Adults unable to consent on their own will not be eligible
• Individuals unable to answer questionnaires in English will not be eligible.
• Pregnant women will not be permitted to enroll as the use of this device in pregnancy is not well studied
• Prisoners will not be included in this study.

Where it is running

• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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