AlopeciaNCT05484973
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
A study testing AMMA Portalbe Scalp Cooling System in people with Alopecia and Chemotherapy-induced Alopecia, run by Cooler Heads Care Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Alopecia, Chemotherapy-induced Alopecia, Hair Loss
- What is being tested?
- AMMA Portalbe Scalp Cooling System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Nov 2024to 30 Sep 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
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 (AC/T, EC/T, TAC, etc.)
- 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
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- 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
- Any reason the investigator does not believe the patient is a good candidate for the study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 245024
Sima Ehsani, MD, 520-621-2449, simaehsani@arizona.edu
- Recruiting
Carle Health
Urbana, Illinois, 61801
Maria Perdekamp, MD, 217-300-5700, Maria.Grosse-Perdekamp@carle.com
About this study
Official title: A Post-market Multi-center Prospective Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Breast Cancer Stages I-III.
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.
Read the detailed description
This is a prospectively enrolling, post-market, on-label study to assess the ability of the AMMA PSCS to prevent hair loss in women receiving CT for early-stage breast cancer, and to assess the safety, tolerability and compliance, patient quality of life, and satisfaction with hair after treatment. Female patients at least 21 years of age with stage I, II, or III breast cancer who are receiving a taxane-containing CT regimen that is scheduled to be completed within six months will be identified and data from the electronic health record (EHR) as well as prospective data will be collected.
AMMA is designed to be used by patients in the chemotherapy infusion center, during transport from the infusion center to home, and after arrival at home. Patients will participate in training in AMMA use and will be asked to bring the device to the chemotherapy infusion center for use during each 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 after the last chemotherapy treatment.
- Conditions
- Alopecia, Chemotherapy-induced Alopecia, Hair Loss, Breast Cancer
- Being tested
- AMMA Portalbe Scalp Cooling System
- Medical subject headings
- Alopecia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMMA Portalbe Scalp Cooling SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: AMMA Portalbe Scalp Cooling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Weeks
Secondary outcomes (8)
Device-related adverse events
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.
Measured: 3 Weeks
Scalp changes
Occurrence of scalp changes in patients during and after use of the AMMA PSCS.
Measured: 3 Weeks
Patient symptoms
Patient symptoms reported during use of the AMMA PSCS as recorded by a symptom survey following each infusion session.
Measured: 3 Weeks
Subject's tolerability
Subject's tolerability of AMMA PSCS treatment demonstrated by responses to questions related to tolerability.
Measured: 3 Weeks
Patient assessment of hair loss
Patient 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.
Measured: 3 Weeks
Patient satisfaction and QoL - Body Image Scale (BIS)
Patient satisfaction and QoL as assessed by the BIS at baseline and posttreatment follow-up.
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: 3 Weeks
Patient satisfaction and QoL - European Organization for Research and Treatment (EORTC) QLQ-BR23
Patient satisfaction and QoL as assessed by the EORTC's QLQ-BR23 at baseline and post-treatment follow-up.
All scores 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: 3 Weeks
Device success
Device success is defined as ability to set up and use the AMMA device as instructed. This will be measured for each treatment and then for all treatments. If a study subject does not complete one or more of the CT visits, that does not constitute a device failure.
Measured: 3 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start8 Nov 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- 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
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooler Heads Care Inc.
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kate Dilligan, Principal investigator, Cooler Heads Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05484973
- Sponsor's protocol ID
- COOL-CLIN-2022-01
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Multi-center Prospective Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Breast Cancer Stages I-III.
- ClinicalTrials.gov ID
- NCT05484973
- Acronym / sponsor ID
- COOL-CLIN-2022-01
- Conditions
- Alopecia, Chemotherapy-induced Alopecia, Hair Loss, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Cooler Heads Care Inc.Other government
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 2 Aug 2022 (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 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.
Detailed description
This is a prospectively enrolling, post-market, on-label study to assess the ability of the AMMA PSCS to prevent hair loss in women receiving CT for early-stage breast cancer, and to assess the safety, tolerability and compliance, patient quality of life, and satisfaction with hair after treatment. Female patients at least 21 years of age with stage I, II, or III breast cancer who are receiving a taxane-containing CT regimen that is scheduled to be completed within six months will be identified and data from the electronic health record (EHR) as well as prospective data will be collected.
AMMA is designed to be used by patients in the chemotherapy infusion center, during transport from the infusion center to home, and after arrival at home. Patients will participate in training in AMMA use and will be asked to bring the device to the chemotherapy infusion center for use during each 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 after the last chemotherapy treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients will use AMMA | Experimental | Device: AMMA Portalbe Scalp Cooling SystemDevice: 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
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 (AC/T, EC/T, TAC, etc.)
- Hormone therapy concurrent with CT. Hormone therapy after CT 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 Portalbe Scalp Cooling SystemAMMA 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 | All patients will use AMMA |
Primary outcome
Hair Loss
Time frame: 3 Weeks
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.
8 secondary outcomes
Device-related adverse events
Time frame: 3 Weeks
Scalp changes
Time frame: 3 Weeks
Patient symptoms
Time frame: 3 Weeks
Subject's tolerability
Time frame: 3 Weeks
Patient assessment of hair loss
Time frame: 3 Weeks
Patient satisfaction and QoL - Body Image Scale (BIS)
Time frame: 3 Weeks
Patient satisfaction and QoL - European Organization for Research and Treatment (EORTC) QLQ-BR23
Time frame: 3 Weeks
Device success
Time frame: 3 Weeks
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 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Kate Dilligan principal investigator
Cooler Heads Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AMMA Portalbe Scalp Cooling System in people with Alopecia and Chemotherapy-induced Alopecia, run by Cooler Heads Care Inc. at 2 sites 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 9 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: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Chris Schultz, BS (9715067552, cschultz@ecr-inc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Loss (time frame: 3 Weeks). 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 Oct 2026.