Status:
WITHDRAWN
A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads
Lead Sponsor:
Cooler Heads Care Inc.
Conditions:
Alopecia
Chemotherapy-induced Alopecia
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05365243
Start Date
August 15 2022
End Date
September 30 2023
Last Update
August 15 2023
Active Locations (1)
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1
White Plains Hospital
White Plains, New York, United States, 10601