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

MedStar Health

Status

Completed

Conditions

Endometrial Cancer

Gynecologic Neoplasm

Breast Cancer

Ovarian Cancer

Treatments

Device: Paxman Scalp Cooling Device

Study type

Interventional

Funder types

Other

Identifiers

NCT04626895

STUDY00000334

Details and patient eligibility

About

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.

Full description

The primary objective is to measure the efficacy of the PSC device in preventing CIA in this diverse patient population with success measured as prevention of >grade 2 alopecia by self-report using the modified Dean scale or the VAS scale in >50% of participants using the intervention. We propose that scalp cooling has distinct efficacy in participants with black or ethnic-minority hair types due to differences in textures, hair thickness.

The study aims include delivery of scalp cooling at each chemotherapy cycle with measurements of CIA at assigned intervals using patient self-report measured by the modified Dean scale and the Visual Analog Scale (VAS) outlined below.

The secondary aims are provider assessments of alopecia as measured by the NCI grading scale of alopecia, adverse effects of scalp cooling procedures such as headaches, dizziness, and pain, reasons for refusal or drop-out of study intervention.

Psychosocial and quality-of- life (QOL) effects of CIA in study participants will be measured using patient reported outcomes. The EORTC QLQ-B45 and Chemotherapy-Induced-Alopecia-Distress Scale (CADS) will be administered at designated time intervals.

Enrollment

15 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.