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

November 6, 2020 updated by: Asma Dilawari, Medstar Health Research Institute

Measuring the Efficacy of Paxman Scalp Cooling to Prevent Chemotherapy Induced Alopecia (CIA) in Black Patients With Stage I-III Breast or Gynecological Cancers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • MedStar Washington Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Scalp Cooling
Patients who be will using the scalp cooling device during chemotherapy will be enrolled in tis arm
Device: Paxman Scalp Cooling Device
Paxman scalp cooling device
No Intervention: Non Scalp-Cooling
Patients who do not use scalp cooling device during chemotherapy will be enrolled in this arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient reported rate of alopecia rate of alopecia
Time Frame: During active chemotherapy and completion of study, an average of 6 months
Patient-reported rate of alopecia as measured by the modified Dean Scale and VAS. Hair preservation is defined in this scale as <50% hair loss (< grade 2) or score of <50 on VAS
During active chemotherapy and completion of study, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psychosocial assessments of chemotherapy-induced alopecia
Time Frame: During active chemotherapy and completion of study, an average of 6 months
Psychosocial assessments of chemotherapy-induced alopecia will be measured by validated CADS (Chemotherapy-induced Alopecia Distress Scale) at designated time intervals. The questionnaire is composed of a 4-point likert Scale and 4 multi-items distress domain that include Physical (2 questions), Emotional (6 questions), Activity (6 questions) and Relationship (1 question). A score of 4 for each domain indicates greater distress. A score of 1 represents no distress.
During active chemotherapy and completion of study, an average of 6 months
Quality of life assessments of chemotherapy-induced alopecia
Time Frame: During active chemotherapy and completion of study, an average of 6 months
Quality of life assessments of chemotherapy-induced alopecia will be measured by EORTC QLQ BR45 questionnaire at designated time intervals. Higher score (4 for each question) is worse.
During active chemotherapy and completion of study, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Collaborators

Paxman

Investigators

  • Principal Investigator: Asma Dilawari, MD, MedStar Washington Hospital Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2019

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

October 28, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000334

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Study protocol, statistical analysis plan, informed consent form, clinical study report and analytic code will be shared.

IPD Sharing Time Frame

Now until 5 years.

IPD Sharing Access Criteria

De-identified outcomes measures and analyses will be shared.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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