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

The registered record

Accession number

NCT06215469

Lead sponsor

University of California, San Francisco (other)

Collaborators

Cooler Heads Care Inc.

Registered conditions naming hair loss

Hair LossAlopeciaChemotherapy-induced Alopecia

Also registered on this record

Breast CancerEarly-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

The first row holds the registered conditions that placed this trial on the pipeline; the second holds everything else the sponsor registered on the same record. Both are shown, and shown apart rather than shaded differently, because leaving the second out would make this trial look more like a hair-loss study than its registration says it is — and because a distinction carried only by colour is not a distinction for every reader.

Interventions

• DeviceAmma Portable Scalp Cooling System (PSCS)
• OtherQuestionnaires

Names and types as registered. The sponsors' free-text descriptions of these interventions are not reproduced: they are written by the party with an interest in the result, and reprinting them inside this site's layout would lend them this site's voice.

Design

Study type

interventional

Phase

Not applicable

Allocation

na

Masking

none

Primary purpose

supportive care

Enrolment

40 participants (estimated)

Sites

1 location in United States

What it measures

1. Percentage of participants with Grade 2 or lower hair loss

   Time frame: Up to 7 months

Primary outcome measures only, as registered. What a trial chose to measure, and when, is the most informative thing about it that is knowable before it reports — a hair-count endpoint at 24 weeks and a patient-satisfaction endpoint at 12 weeks are not the same study.

Who can take part

Sex

all

Age

21 Years

Healthy volunteers

not accepted

A summary of three registered fields, not the eligibility criteria. The full inclusion and exclusion criteria, the recruiting sites and the study contacts are on the registry record, which is the only place they are maintained. This site has no relationship with this trial and cannot refer anyone to it.

Registered dates

Study start

16 May 2024 (actual)

Primary completion

31 December 2029 (estimated)

Study completion

31 December 2029 (estimated)

First posted

22 January 2024 (actual)

Last update posted

22 April 2026 (actual)

"Estimated" and "actual" are the registry's own labels: an estimated date is a plan, and plans move. A date is printed at the precision it was registered at: this record registers a primary completion to the day, so a day is what is shown. Where a sponsor registers only a month, only a month is shown.

Results

This trial has not reported results. ClinicalTrials.gov holds no results record for it. That is the ordinary state of a trial that is running or about to run, and it means there is nothing here to tell you about whether the intervention works — including nothing negative. If this page implied otherwise it would be wrong.

On this site

Guides covering the condition this trial is registered for. They are about published evidence; this page is about a registration, and the two do not overlap.

Diffuse Thinning vs. Pattern Baldness: How to Tell the Difference (2026 Guide)How to Tell If You're Going Bald: Early Signs & Self-Assessment Guide (2026)Chemotherapy Hair Loss: Which Drugs Cause It, What Scalp Cooling Achieves, and the Regrowth Timeline

Where this came from

Read from the ClinicalTrials.gov API on 6 September 2026 and rebuilt into this page without alteration. ClinicalTrials.gov is a service of the U.S. National Library of Medicine and is the authority on this record; where this page and the registry disagree, the registry is right. This page is not affiliated with or endorsed by NLM or NIH, or with the sponsor of this trial.

Open NCT06215469 on ClinicalTrials.gov · All 157 trials in the pipeline