AlopeciaNCT05365243
A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads
A study testing AMMA Portalbe Scalp Cooling System in people with Alopecia and Chemotherapy-induced Alopecia, run by Cooler Heads Care Inc. at 1 site in United States.
Trial summary
Eligible patients will be recruited prior to initiation of chemotherapy for any stage breast or gynecologic cancer. Patients will undergo training in the use of the AMMA Portable Scalp Cooling System and will use the device during each of their chemotherapy treatments. 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 age 21 years or older at the time of signing informed consent.
- Documented pathologic diagnosis of invasive breast or gynecologic cancer, any stage, requiring treatment with a taxane-containing chemotherapy regimen
- Planned start of treatment with taxane-based chemotherapy in the adjuvant, neoadjuvant or advanced setting
- Plan to complete chemotherapy within 6 months of treatment start
- If received prior chemotherapy causing hair loss, >/= 2 years since last chemotherapy dose and complete recovery of hair
- ECOG performance status 0-1
- Willing and able to sign informed consent for study procedures
- Willing and able to participate in all study procedures
Who cannot join
- Plan to use chemotherapy regimen other than that listed in inclusion criteria, including any anthracycline-based regimen
- Plan to initiate bone marrow ablation chemotherapy
- History of or plan to initiate whole or partial brain or skull irradiation
- Hormone therapy concurrent with current chemotherapy regimen
- Existing or suspected scalp metastases
- History of concomitant diagnosis of: autoimmune disease affecting hair; cryoglobulinemia; untreated iron deficiency with or without anemia; cold agglutination disease; post-traumatic cold dystrophy; untreated or poorly controlled hyper- or hypothyroidism
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- Female pattern baldness
- History of persistent chemotherapy-induced alopecia from prior chemotherapy
- Concomitant exposure to investigational agents, drugs, devices or procedures that cause hair loss
- Concomitant other solid tumor or hematologic malignancy in addition to the current diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System
Eligible patients will be recruited prior to initiation of chemotherapy for any stage breast or gynecologic cancer. Patients will undergo training in the use of the AMMA Portable Scalp Cooling System and will use the device during each of their chemotherapy treatments. Quality of life and experience of use questionnaires will be completed. Scalp photos and an assessment of hair loss will be preformed at enrollment and at the end of study participation.
Read the detailed description
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 2 hours after chemotherapy. Scalp photos will be obtained at baseline and after the last chemotherapy treatment. Patients will be asked to complete the following questionnaires: training evaluation after training is complete; and symptoms from device use, experience with device use and self-assessment of hair loss after each chemotherapy treatment.
- 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 is indicated for use in chemotherapy infusion centers, during transit from the infusion center and at 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 |
|---|---|---|
| Interventional | Experimental | All patients will use AMMA Receives: Device: AMMA Portalbe Scalp Cooling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with AMMA use
Patient-reported questionnaire, including yes/no answers and description of the effectiveness and clarity of the training provided
Measured: 6 months
Experience of AMMA use
Patient-reported questionnaire, including questions on a 1 to 4 scale, where 1 is not at all and 4 is very much, regarding ease of product setup and use in the clinic, during the ride home and at home
Measured: 6 months
Symptoms associated with AMMA use
Patient-reported questionnaire, including questions on a 1 to 4 scale, where 1 is not at all and 4 is very much, regarding amount of hair loss and the impact of any hair loss on daily activities
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start15 Aug 2022 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Why it stopped: Single-site study, site was unable to participate
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooler Heads Care Inc.
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kate Dilligan, Study director, Cooler Heads Care Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365243
- Sponsor's protocol ID
- WPH 2201
- Status last verified
- Aug 2023
- First submitted
- 4 May 2022
- Last updated
- 15 Aug 2023
- 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 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System
- ClinicalTrials.gov ID
- NCT05365243
- Acronym / sponsor ID
- WPH 2201
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Single-site study, site was unable to participate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cooler Heads Care Inc.Other government
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 9 May 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.
Eligible patients will be recruited prior to initiation of chemotherapy for any stage breast or gynecologic cancer. Patients will undergo training in the use of the AMMA Portable Scalp Cooling System and will use the device during each of their chemotherapy treatments. Quality of life and experience of use questionnaires will be completed. Scalp photos and an assessment of hair loss will be preformed at enrollment and at the end of study participation.
Detailed description
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 2 hours after chemotherapy. Scalp photos will be obtained at baseline and after the last chemotherapy treatment. Patients will be asked to complete the following questionnaires: training evaluation after training is complete; and symptoms from device use, experience with device use and self-assessment of hair loss after each 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 |
|---|---|---|
| Interventional | Experimental | Device: AMMA Portalbe Scalp Cooling SystemAll patients will use AMMA |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female age 21 years or older at the time of signing informed consent.
- Documented pathologic diagnosis of invasive breast or gynecologic cancer, any stage, requiring treatment with a taxane-containing chemotherapy regimen
- Planned start of treatment with taxane-based chemotherapy in the adjuvant, neoadjuvant or advanced setting
- Plan to complete chemotherapy within 6 months of treatment start
- If received prior chemotherapy causing hair loss, >/= 2 years since last chemotherapy dose and complete recovery of hair
Key exclusion criteria (10 listed)
- Plan to use chemotherapy regimen other than that listed in inclusion criteria, including any anthracycline-based regimen
- Plan to initiate bone marrow ablation chemotherapy
- History of or plan to initiate whole or partial brain or skull irradiation
- Hormone therapy concurrent with current chemotherapy regimen
- Existing or suspected scalp metastases
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 is indicated for use in chemotherapy infusion centers, during transit from the infusion center and at 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 | Interventional |
Primary outcome
Compliance with AMMA use
Time frame: 6 months
Patient-reported questionnaire, including yes/no answers and description of the effectiveness and clarity of the training provided
Experience of AMMA use
Time frame: 6 months
Patient-reported questionnaire, including questions on a 1 to 4 scale, where 1 is not at all and 4 is very much, regarding ease of product setup and use in the clinic, during the ride home and at home
Symptoms associated with AMMA use
Time frame: 6 months
Patient-reported questionnaire, including questions on a 1 to 4 scale, where 1 is not at all and 4 is very much, regarding amount of hair loss and the impact of any hair loss on daily activities
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- 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. This study is not recruiting at the moment.
Kate Dilligan study director
Cooler Heads Care Inc.
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 Portalbe Scalp Cooling System in people with Alopecia and Chemotherapy-induced Alopecia, run by Cooler Heads Care Inc. 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 10 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: withdrawn, as of the sponsor's last update on 15 Aug 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Compliance with AMMA use (time frame: 6 months). The study lists 3 primary outcomes in all. 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 15 Aug 2023.