RECRUITING

Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)

Conditions

Breast Cancer Early-stage Breast Cancer Hair Loss Alopecia Chemotherapy-induced Alopecia Hair Loss Prevention Amma

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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 post-market, prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer.

Official Title

Amma™ Portable Scalp Cooling System (PSCS) Study: A Post-market Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Early-stage Breast Cancer

Quick Facts

Study Start:2024-05-16

Study Completion:2025-08-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06215469

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:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Participants must have histologically or cytologically confirmed breast cancer, stage I, II, or III. 2. A planned taxane-containing chemotherapy (CT) regimen in the adjuvant or neoadjuvant setting with curative intent. 3. Plan to complete the current CT regimen within six months. 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. At least two years out from the last CT causing hair loss with complete recovery of hair. 6. Age \>=21 years 7. Eastern Cooperative Oncology Group (ECOG) performance status of \<=1. 8. Ability to understand and the willingness to sign a written informed consent document.	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 (doxorubicin and cyclophosphamide followed by paclitaxel (AC/T), epirubicin, cyclophosphamide, and docetaxel or paclitaxel (EC/T), docetaxel (Taxotere), doxorubicin hydrochloride (Adriamycin), and cyclophosphamide (TAC), etc.) 5. Hormone therapy after CT is permitted and ovarian function suppression during chemotherapy is permitted. 6. Concurrent 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 alopecia (any grade) 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. Concurrent treatment with any investigational agent. 16. Any reason the investigator does not believe the patient is a good candidate for the study. 17. Has received systemic cytotoxic therapies within 3 weeks of first dose. Concomitant administration of Luteinizing hormone-releasing hormone (LHRH) analogues is allowed.

Inclusion Criteria

Exclusion Criteria

1. Participants must have histologically or cytologically confirmed breast cancer, stage I, II, or III.
2. A planned taxane-containing chemotherapy (CT) regimen in the adjuvant or neoadjuvant setting with curative intent.
3. Plan to complete the current CT regimen within six months.
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. At least two years out from the last CT causing hair loss with complete recovery of hair.
6. Age \>=21 years
7. Eastern Cooperative Oncology Group (ECOG) performance status of \<=1.
8. Ability to understand and the willingness to sign a written informed consent document.

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 (doxorubicin and cyclophosphamide followed by paclitaxel (AC/T), epirubicin, cyclophosphamide, and docetaxel or paclitaxel (EC/T), docetaxel (Taxotere), doxorubicin hydrochloride (Adriamycin), and cyclophosphamide (TAC), etc.)
5. Hormone therapy after CT is permitted and ovarian function suppression during chemotherapy is permitted.
6. Concurrent 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 alopecia (any grade) 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. Concurrent treatment with any investigational agent.
16. Any reason the investigator does not believe the patient is a good candidate for the study.
17. Has received systemic cytotoxic therapies within 3 weeks of first dose. Concomitant administration of Luteinizing hormone-releasing hormone (LHRH) analogues is allowed.

Contacts and Locations

Study Contact

Ivy Ow

CONTACT

(415) 353-7873

Ivy.Wong@ucsf.edu

Principal Investigator

Hope Rugo, MD

PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94143

United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

Hope Rugo, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

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 Date2024-05-16

Study Completion Date2025-08-31

Study Record Updates

Study Start Date2024-05-16

Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

Hair Loss Prevention
Amma

Additional Relevant MeSH Terms

Breast Cancer
Early-stage Breast Cancer
Hair Loss
Alopecia
Chemotherapy-induced Alopecia