A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads (NCT05365243) | Clinical Trial Compass
WithdrawnNot Applicable
A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads
Stopped: Single-site study, site was unable to participate
United States0Started 2022-08-15
Plain-language 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. 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.
Who can participate
Age range
21 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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, devi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.