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Trial Title:
Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)
NCT ID:
NCT06215469
Condition:
Breast Cancer
Early-stage Breast Cancer
Hair Loss
Alopecia
Chemotherapy-induced Alopecia
Conditions: Official terms:
Breast Neoplasms
Alopecia
Alopecia Areata
Conditions: Keywords:
Hair Loss Prevention
Amma
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Amma Portable Scalp Cooling System (PSCS)
Description:
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.
Arm group label:
Portable Scalp Cooling System (PSCS)
Other name:
Portable Scalp Cooling System (PSCS)
Intervention type:
Other
Intervention name:
Questionnaires
Description:
Quality of Life (QoL) and device usage questionnaires
Arm group label:
Portable Scalp Cooling System (PSCS)
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.
Criteria for 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.
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.
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.
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ivy Ow
Phone:
415-353-7873
Email:
Ivy.Wong@ucsf.edu
Investigator:
Last name:
Hope Rugo, MD
Email:
Principal Investigator
Investigator:
Last name:
Laura Esserman, MD
Email:
Sub-Investigator
Start date:
May 16, 2024
Completion date:
August 31, 2025
Lead sponsor:
Agency:
University of California, San Francisco
Agency class:
Other
Collaborator:
Agency:
Cooler Heads Care Inc.
Agency class:
Other
Source:
University of California, San Francisco
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06215469
