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

Primary Purpose

Breast Cancer, Ovarian Cancer, Gynecologic Neoplasm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Paxman Scalp Cooling Device
Sponsored by
Medstar Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • MedStar Washington Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Scalp Cooling

Non Scalp-Cooling

Arm Description

Patients who be will using the scalp cooling device during chemotherapy will be enrolled in tis arm

Patients who do not use scalp cooling device during chemotherapy will be enrolled in this arm.

Outcomes

Primary Outcome Measures

Patient reported rate of alopecia rate of alopecia
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

Secondary Outcome Measures

Psychosocial assessments of chemotherapy-induced alopecia
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.
Quality of life assessments of chemotherapy-induced alopecia
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.

Full Information

First Posted
October 28, 2020
Last Updated
November 6, 2020
Sponsor
Medstar Health Research Institute
Collaborators
Paxman
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1. Study Identification

Unique Protocol Identification Number
NCT04626895
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medstar Health Research Institute
Collaborators
Paxman

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Ovarian Cancer, Gynecologic Neoplasm, Endometrial Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scalp Cooling
Arm Type
Other
Arm Description
Patients who be will using the scalp cooling device during chemotherapy will be enrolled in tis arm
Arm Title
Non Scalp-Cooling
Arm Type
No Intervention
Arm Description
Patients who do not use scalp cooling device during chemotherapy will be enrolled in this arm.
Intervention Type
Device
Intervention Name(s)
Paxman Scalp Cooling Device
Intervention Description
Paxman scalp cooling device
Primary Outcome Measure Information:
Title
Patient reported rate of alopecia rate of alopecia
Description
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
Time Frame
During active chemotherapy and completion of study, an average of 6 months
Secondary Outcome Measure Information:
Title
Psychosocial assessments of chemotherapy-induced alopecia
Description
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.
Time Frame
During active chemotherapy and completion of study, an average of 6 months
Title
Quality of life assessments of chemotherapy-induced alopecia
Description
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.
Time Frame
During active chemotherapy and completion of study, an average of 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asma Dilawari, MD
Organizational Affiliation
Medstar Washington Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
33512741
Citation
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.
Results Reference
derived

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

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