Efficacy of Paxman Scalp Cooling to Prevent Chemo Induced Alopecia in Black Patients With Breast or GYN Cancers
NCT ID: NCT04626895
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2019-06-04
2020-10-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Scalp Cooling
Patients who be will using the scalp cooling device during chemotherapy will be enrolled in tis arm
Paxman Scalp Cooling Device
Paxman scalp cooling device
Non Scalp-Cooling
Patients who do not use scalp cooling device during chemotherapy will be enrolled in this arm.
No interventions assigned to this group
Interventions
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Paxman Scalp Cooling Device
Paxman scalp cooling device
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Paxman
UNKNOWN
Medstar Health Research Institute
OTHER
Responsible Party
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Asma Dilawari
Assistant Professor of Medicine
Principal Investigators
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Asma Dilawari, MD
Role: PRINCIPAL_INVESTIGATOR
Medstar Health Research Institute
Locations
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MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Countries
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References
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Dilawari A, Gallagher C, Alintah P, Chitalia A, Tiwari S, Paxman R, Adams-Campbell L, Dash C. Does Scalp Cooling Have the Same Efficacy in Black Patients Receiving Chemotherapy for Breast Cancer? Oncologist. 2021 Apr;26(4):292-e548. doi: 10.1002/onco.13690. Epub 2021 Feb 17.
Other Identifiers
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STUDY00000334
Identifier Type: -
Identifier Source: org_study_id