Clinical trial NCT05365243: A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads
Official title: A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Alopecia
Chemotherapy-induced Alopecia
Hair Loss
Breast Cancer
Gynecologic Cancer
Lead sponsor: Cooler Heads Care Inc.
Sponsor class: OTHER_GOV
First posted: 2022-05-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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, devices or procedures that cause hair loss
* Concomitant other solid tumor or hematologic malignancy in addition to the current diagnosis

Primary outcomes:
measure: Compliance with AMMA use
timeFrame: 6 months
measure: Experience of AMMA use
timeFrame: 6 months
measure: Symptoms associated with AMMA use
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: White Plains
country: United States
facility: White Plains Hospital
state: New York
Study officials:
affiliation: Cooler Heads Care Inc.
name: Kate Dilligan
role: STUDY_DIRECTOR
References: