Brief Title
Efficacy of Paxman Scalp Cooling to Prevent Chemo Induced Alopecia in Black Patients With Breast or GYN Cancers
Official Title
Measuring the Efficacy of Paxman Scalp Cooling to Prevent Chemotherapy Induced Alopecia (CIA) in Black Patients With Stage I-III Breast or Gynecological Cancers
Brief Summary
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.
Detailed 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.
Study Type
Interventional
Primary Outcome
Patient reported rate of alopecia rate of alopecia
Secondary Outcome
Psychosocial assessments of chemotherapy-induced alopecia
Condition
Breast Cancer
Intervention
Paxman Scalp Cooling Device
Study Arms / Comparison Groups
Scalp Cooling
Description: Patients who be will using the scalp cooling device during chemotherapy will be enrolled in tis arm
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
15
Start Date
June 4, 2019
Completion Date
October 1, 2020
Primary Completion Date
August 31, 2020
Eligibility Criteria
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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Asma Dilawari, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT04626895
Organization ID
STUDY00000334
Responsible Party
Principal Investigator
Study Sponsor
Medstar Health Research Institute
Collaborators
Paxman
Study Sponsor
Asma Dilawari, MD, Principal Investigator, Medstar Washington Hospital Center
Verification Date
November 2020