Breast CancerNCT06215469
Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)
A study testing Amma Portable Scalp Cooling System (PSCS) and Questionnaires in people with Breast Cancer and Early-stage Breast Cancer, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer, Early-stage Breast Cancer, Hair Loss
- What is being tested?
- Amma Portable Scalp Cooling System (PSCS) and Questionnaires
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.)
- 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.
Show all 17Show fewer
- 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.
- Has received systemic cytotoxic therapies within 3 weeks of first dose. Concomitant administration of Luteinizing hormone-releasing hormone (LHRH) analogues is allowed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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
- Being tested
- Amma Portable Scalp Cooling System (PSCS), Questionnaires
- Keywords
- Hair Loss Prevention, Amma
- Medical subject headings
- Breast Neoplasms, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amma Portable Scalp Cooling System (PSCS)Device
Also called 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.
QuestionnairesOther
Quality of Life (QoL) and device usage questionnaires
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Amma Portable Scalp Cooling System (PSCS); Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 months
Secondary outcomes (4)
Proportion of participants with device-related Adverse Events
The proportion of participants with any adverse events related to Amma PSCS device use, classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) and as reported in the Patient Symptoms and Tolerance Questionnaire
Measured: Up to 7 months
Change in total score on the Body Image Scale (BIS)
The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance.
Measured: Up to 7 months
Change in scores on the EORTC- QLQ-BR23
The EORTC-QLQ-BR23 is a questionnaire for measuring the quality of life in patients with breast cancer. Raw scores are computed but summing all items and then are linearly transformed to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score. A high QOL is represented by a high score for global health status or QOL. More severe symptoms or problems are represented by high symptom scores or items.
Measured: Up to 7 months
Proportion of participants assessment of hair loss as <50%
Participant assessment of hair loss as recorded in the Alopecia Self-Report Survey at post-treatment follow-up according to the following scale: <50% of normal for the patient, or ≥50% hair loss will be reported.
Measured: At 3 weeks after completion of last CT treatment/ infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start16 May 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Cooler Heads Care Inc.
- Responsible party
- Sponsor
- Investigators
- Jo Chien, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215469
- Sponsor's protocol ID
- 238010
- Other IDs
- COOL-CLIN-2023-01, 23-39927, NCI-2024-01083
- Status last verified
- Apr 2026
- First submitted
- 10 Jan 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be shared with Cooler Heads, Inc and may be shared with other researchers as detailed in the informed consent.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06215469
- Acronym / sponsor ID
- 238010
- Conditions
- Breast Cancer, Early-stage Breast Cancer, Hair Loss, Alopecia, Chemotherapy-induced Alopecia
- Keywords
- Hair Loss Prevention, Amma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Cooler Heads Care Inc.
- Study start
- 16 May 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Portable Scalp Cooling System (PSCS) | Experimental | Device: Amma Portable Scalp Cooling System (PSCS), Other: QuestionnairesParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
- 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.)
- Hormone therapy after CT is permitted and ovarian function suppression during chemotherapy is permitted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amma Portable Scalp Cooling System (PSCS)Also: 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. | Device | Portable Scalp Cooling System (PSCS) |
| QuestionnairesQuality of Life (QoL) and device usage questionnaires | Other | Portable Scalp Cooling System (PSCS) |
Primary outcome
Percentage of participants with Grade 2 or lower hair loss
Time frame: Up to 7 months
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.
4 secondary outcomes
Proportion of participants with device-related Adverse Events
Time frame: Up to 7 months
Change in total score on the Body Image Scale (BIS)
Time frame: Up to 7 months
Change in scores on the EORTC- QLQ-BR23
Time frame: Up to 7 months
Proportion of participants assessment of hair loss as <50%
Time frame: At 3 weeks after completion of last CT treatment/ infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with Cooler Heads, Inc and may be shared with other researchers as detailed in the informed consent.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jo Chien, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amma Portable Scalp Cooling System (PSCS) and Questionnaires in people with Breast Cancer and Early-stage Breast Cancer, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with Grade 2 or lower hair loss (time frame: Up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.