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

NCT04626895 | Completed FDA Device

• 1 other identifier: STUDY00000334
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Ovarian Cancer; Gynecologic Neoplasm; Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Psychosocial assessments of chemotherapy-induced alopecia

  During active chemotherapy and completion of study, an average of 6 months

• Quality of life assessments of chemotherapy-induced alopecia

  During active chemotherapy and completion of study, an average of 6 months

Study Arms (2)

Scalp Cooling

OTHER

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

Device: Paxman Scalp Cooling Device

Non Scalp-Cooling

NO INTERVENTION

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

Interventions

Paxman Scalp Cooling Device DEVICE

Paxman scalp cooling device

Scalp Cooling

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medstar Health Research Institute: lead
• Paxman: collaborator

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (1)

• 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.

  PMID: 33512741 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Ovarian Neoplasms; Genital Neoplasms, Female; Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases

Study Officials

• Asma Dilawari, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 13, 2020
• Study Start: June 4, 2019
• Primary Completion: August 31, 2020
• Study Completion: October 1, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Now until 5 years.
• Access Criteria: De-identified outcomes measures and analyses will be shared.

Locations

US (1)