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

NCT ID: NCT06215469

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-16
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

PRIMARY OBJECTIVE:

I. To evaluate hair loss as assessed by the investigator at 3 weeks (±1 week) after the completion of the last chemotherapy (CT) treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE) by comparing post-treatment photographs to pre-treatment photographs.

SECONDARY OBJECTIVES:

I. To assess safety of the Amma PSCS based on the occurrence of device-related adverse events, occurrence of scalp changes determined by physical examination, and patient symptoms with use of the PSCS.

II. To evaluate hair loss as measured by the patient at 3 weeks (±1 week) after the completion of the last treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE v5.0 or above) by comparing post-treatment photographs to baseline photographs.

III. To assess tolerability/compliance with use of the PSCS. IV. To assess patient quality of life and satisfaction with hair preservation after Amma PSCS usage using the Body Image Scale (BIS) and the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) for Breast Cancer (EORTC-QLQ-BR23) questionnaire.

OUTLINE:

Participants will use the AMMA PSCS while receiving non-investigational, chemotherapy treatments. Participants may continue device usage through their last cycle of chemotherapy (approximately 6 months) and will be followed for 30 days after the last device usage date, until removal from study, or until death, whichever occurs first.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Portable Scalp Cooling System (PSCS)

Participants will participate in training in AMMA use and will be asked to bring the device for use during each non-investigational, chemotherapy treatment visit. The device will be used for 30 minutes prior to the start of chemotherapy, during chemotherapy, and for at least 2.5 hours after chemotherapy. Scalp photos will be obtained at baseline and 3 weeks after the last chemotherapy treatment. Questionnaires will be given throughout the study and 3 weeks after the last after the last chemotherapy treatment.

Group Type: EXPERIMENTAL

Amma Portable Scalp Cooling System (PSCS)

Intervention Type: DEVICE

The unit is a compact, mobile refrigeration unit which circulates liquid coolant at low pressure through a special cooling cap on the participant's head, administered during non-investigational, cancer treatment.

Questionnaires

Intervention Type: OTHER

Quality of Life (QoL) and device usage questionnaires

Interventions

Amma Portable Scalp Cooling System (PSCS)

The unit is a compact, mobile refrigeration unit which circulates liquid coolant at low pressure through a special cooling cap on the participant's head, administered during non-investigational, cancer treatment.

Intervention Type: DEVICE

Questionnaires

Quality of Life (QoL) and device usage questionnaires

Intervention Type: OTHER

Other Intervention Names

Portable Scalp Cooling System (PSCS)

Eligibility Criteria

Inclusion 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.

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cooler Heads Care Inc.

OTHER_GOV

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jo Chien, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ivy Ow

Role: CONTACT

Ivy.Wong@ucsf.edu

(415) 353-7873

Facility Contacts

Ivy Ow

Role: primary

Ivy.Wong@ucsf.edu

415-353-7873

Other Identifiers

COOL-CLIN-2023-01

Identifier Type: OTHER

Identifier Source: secondary_id

23-39927

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2024-01083

Identifier Type: REGISTRY

Identifier Source: secondary_id

238010

Identifier Type: -

Identifier Source: org_study_id