RECRUITING

Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss

Conditions

Alopecia Chemotherapy-induced Alopecia Hair Loss Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer. Additionally, the purpose is also to assess the safety, tolerability and compliance, quality of life, and satisfaction with hair preservation after CT treatment.

Official Title

A Post-market Multi-center Prospective Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Breast Cancer Stages I-III.

Quick Facts

Study Start:2024-11-08

Study Completion:2026-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05484973

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.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Female patients ≥ 21 years of age 2. Documented diagnosis of breast cancer, stage I, II, or III 3. A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent 4. Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such as cyclophosphamide, or carboplatin Note: Targeted and/or hormonal therapies intended for use after completion of the taxane-containing CT regimen will not be considered part of the study treatment period, and the AMMA PSCS will not be used during the post-CT targeted and/or hormonal therapy period 5. Plan to complete the current CT regimen within six months 6. At least two years out from the last CT causing hair loss with complete recovery of hair 7. Karnofsky17 performance status 80% or greater 8. Willing and able to sign informed consent for this study 9. Willing and able to complete all required study procedures	1. Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale 2. Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss, others 3. A history of whole brain radiation 4. Plans to use a CT regimen other than those specified in the inclusion criteria; specifically, a regimen not including paclitaxel or docetaxel or a regimen including an anthracycline (AC/T, EC/T, TAC, etc.) 5. Hormone therapy concurrent with CT. Hormone therapy after CT is permitted 6. Current and/or prior use of hair growth products, such as Nutrafol, minoxidil, and Keranique 7. A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up 8. History of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens 9. History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss 10. Cold sensitivity 11. Intercurrent life-threatening malignancy 12. Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism 13. History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia 14. Concurrent hematologic malignancy 15. Participation in any other clinical investigation 16. Concurrent treatment with any investigational agent 17. Any reason the investigator does not believe the patient is a good candidate for the study

Inclusion Criteria

Exclusion Criteria

1. Female patients ≥ 21 years of age
2. Documented diagnosis of breast cancer, stage I, II, or III
3. A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent
4. Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such as cyclophosphamide, or carboplatin Note: Targeted and/or hormonal therapies intended for use after completion of the taxane-containing CT regimen will not be considered part of the study treatment period, and the AMMA PSCS will not be used during the post-CT targeted and/or hormonal therapy period
5. Plan to complete the current CT regimen within six months
6. At least two years out from the last CT causing hair loss with complete recovery of hair
7. Karnofsky17 performance status 80% or greater
8. Willing and able to sign informed consent for this study
9. Willing and able to complete all required study procedures

1. Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
2. Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss, others
3. A history of whole brain radiation
4. Plans to use a CT regimen other than those specified in the inclusion criteria; specifically, a regimen not including paclitaxel or docetaxel or a regimen including an anthracycline (AC/T, EC/T, TAC, etc.)
5. Hormone therapy concurrent with CT. Hormone therapy after CT is permitted
6. Current and/or prior use of hair growth products, such as Nutrafol, minoxidil, and Keranique
7. A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up
8. History of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
9. History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss
10. Cold sensitivity
11. Intercurrent life-threatening malignancy
12. Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism
13. History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
14. Concurrent hematologic malignancy
15. Participation in any other clinical investigation
16. Concurrent treatment with any investigational agent
17. Any reason the investigator does not believe the patient is a good candidate for the study

Contacts and Locations

Study Contact

Chris Schultz, BS

CONTACT

9715067552

cschultz@ecr-inc.com

Principal Investigator

Kate Dilligan

PRINCIPAL_INVESTIGATOR

Cooler Heads Inc.

Study Locations (Sites)

University of Arizona

Tucson, Arizona, 245024

United States

Carle Health

Urbana, Illinois, 61801

United States

Collaborators and Investigators

Sponsor: Cooler Heads Care Inc.

Kate Dilligan, PRINCIPAL_INVESTIGATOR, Cooler Heads Inc.

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 Registration Dates

Study Start Date2024-11-08

Study Completion Date2026-09-30

Study Record Updates

Study Start Date2024-11-08

Study Completion Date2026-09-30

Terms related to this study

Additional Relevant MeSH Terms

Alopecia
Chemotherapy-induced Alopecia
Hair Loss
Breast Cancer