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

NCT06215469 | Active Not Recruiting DMC FDA Device

• 4 other identifiers: 238010COOL-CLIN-2023-0123-39927NCI-2024-01083
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Hair Loss Prevention; Amma

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with Grade 2 or lower hair loss

  The percentage of participants with Grade 1 hair loss (defined by the NCI CTCAE as \<50% of normal for that individual that is not obvious from a distance but only on close inspection) with supported photographs of the scalp taken at baseline and 3 weeks after completion of last non-investigational CT treatment/ infusion for comparison and evaluation will be reported with a 95% confidence interval.

  Up to 7 months

Secondary Outcomes (4)

• Proportion of participants with device-related Adverse Events

  Up to 7 months

• Change in total score on the Body Image Scale (BIS)

  Up to 7 months

• Change in scores on the EORTC- QLQ-BR23

  Up to 7 months

• Proportion of participants assessment of hair loss as <50%

  At 3 weeks after completion of last CT treatment/ infusion

Study Arms (1)

Portable Scalp Cooling System (PSCS)

EXPERIMENTAL

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.

Device: Amma Portable Scalp Cooling System (PSCS); Other: Questionnaires

Interventions

Amma Portable Scalp Cooling System (PSCS) 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.

Also known as: Portable Scalp Cooling System (PSCS)

Portable Scalp Cooling System (PSCS)

Questionnaires OTHER

Quality of Life (QoL) and device usage questionnaires

Portable Scalp Cooling System (PSCS)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

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 after CT is permitted and ovarian function suppression during chemotherapy is permitted.
• Concurrent 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 alopecia (any grade) 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.
• Concurrent treatment with any investigational agent.
• Any reason the investigator does not believe the patient is a good candidate for the study.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Cooler Heads Care Inc.: collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Alopecia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jo Chien, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 22, 2024
• Study Start: May 16, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)