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

NCT05484973 | Recruiting FDA Device

• 1 other identifier: COOL-CLIN-2022-01
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hair Loss

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

  3 Weeks

Secondary Outcomes (8)

• Device-related adverse events

  3 Weeks

• Scalp changes

  3 Weeks

• Patient symptoms

  3 Weeks

• Subject's tolerability

  3 Weeks

• Patient assessment of hair loss

  3 Weeks

Study Arms (1)

All patients will use AMMA

EXPERIMENTAL

Device: AMMA Portalbe Scalp Cooling System AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center andat home and is intended for use by patients who are undergoing chemotherapy treatment and who want to reduce the likelihood of chemotherapy-induced alopecia.

Device: AMMA Portalbe Scalp Cooling System

Interventions

AMMA Portalbe Scalp Cooling System DEVICE

AMMA Portalbe Scalp Cooling System AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center andat home and is intended for use by patients who are undergoing chemotherapy treatment and who want to reduce the likelihood of chemotherapy-induced alopecia.

All patients will use AMMA

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients ≥ 21 years of age
• Documented diagnosis of breast cancer, stage I, II, or III
• A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent
• 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
• Plan to complete the current CT regimen within six months
• At least two years out from the last CT causing hair loss with complete recovery of hair
• Karnofsky17 performance status 80% or greater
• Willing and able to sign informed consent for this study
• Willing and able to complete all required study procedures

You may not qualify if:

• Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
• Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss, others
• A history of whole brain radiation
• Hormone therapy concurrent with CT. Hormone therapy after CT is permitted
• Current and/or prior use of hair growth products, such as Nutrafol, minoxidil, and Keranique
• A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up
• History of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
• History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss
• Cold sensitivity
• Intercurrent life-threatening malignancy
• Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism
• History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
• Concurrent hematologic malignancy
• Participation in any other clinical investigation
• Concurrent treatment with any investigational agent

Sponsors & Collaborators

• Cooler Heads Care Inc.: lead

Study Sites (2)

University of Arizona

Tucson, Arizona, 245024, United States

RECRUITING

Carle Health

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Alopecia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases

Study Officials

• Kate Dilligan

  Cooler Heads Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Schultz, BS

CONTACT

9715067552; cschultz@ecr-inc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 2, 2022
• Study Start: November 8, 2024
• Primary Completion: March 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)