A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads

Withdrawn before enrolling · Not applicable

Conditions studied: Alopecia, Chemotherapy-induced Alopecia, Hair Loss, Breast Cancer, Gynecologic Cancer

In brief

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.

Key facts

Study ID

NCT05365243

Run by

Cooler Heads Care Inc.

People needed

0

Starts

2022-08-15

Expected to finish

2023-09-30

Last updated by the study team

2023-08-15

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• White Plains Hospital — White Plains, New York, United States

Full record on ClinicalTrials.gov

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