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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04626895
• Other study ID #: STUDY00000334
• Status: Completed
• Phase: N/A
• Start date: June 4, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: November 2020
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 1, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Breast Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Genital Neoplasms, Female
• Gynecologic Neoplasm
• Ovarian Cancer

Intervention

Device:
• Paxman Scalp Cooling Device
Paxman scalp cooling device

Locations

Country	Name	City	State
United States	MedStar Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Medstar Health Research Institute	Paxman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	During active chemotherapy and completion of study, an average of 6 months
Secondary	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.	During active chemotherapy and completion of study, an average of 6 months
Secondary	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.	During active chemotherapy and completion of study, an average of 6 months