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Trial Title:
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
NCT ID:
NCT05484973
Condition:
Alopecia
Chemotherapy-induced Alopecia
Hair Loss
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Alopecia
Alopecia Areata
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet 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 Portalbe Scalp Cooling System
Description:
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.
Arm group label:
All patients will use AMMA
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female patients ≥ 21 years of age
2. Documented diagnosis of breast cancer, stage I, II, or III
3. A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with
curative intent
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. Plan to complete the current CT regimen within six months
6. At least two years out from the last CT causing hair loss with complete recovery of
hair
7. Karnofsky17 performance status 80% or greater
8. Willing and able to sign informed consent for this study
9. Willing and able to complete all required study procedures
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 (AC/T, EC/T, TAC, etc.)
5. Hormone therapy concurrent with CT. Hormone therapy after CT is permitted
6. Current and/or prior 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 grade 2 (or higher) alopecia 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. Participation in any other clinical investigation
16. Concurrent treatment with any investigational agent
17. Any reason the investigator does not believe the patient is a good candidate for the
study
Gender:
Female
Gender based:
Yes
Gender description:
Breast cancer
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 31, 2024
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Cooler Heads Care Inc.
Agency class:
Other
Source:
Cooler Heads Care Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05484973