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

Not Applicable

Withdrawn

• Conditions: Gynecologic Cancer; Chemotherapy-induced Alopecia; Breast Cancer; Alopecia; Hair Loss
• Interventions: Device: AMMA Portalbe Scalp Cooling System

• Registration Number: NCT05365243
• Lead Sponsor: Cooler Heads Care Inc.

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.

Study Timeline

• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Study Start: 2022-08-15
• Primary Completion: 2023-06-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-11
• Last Update Posted: 2023-08-15
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional	AMMA Portalbe Scalp Cooling System	All patients will use AMMA

Primary Outcome Measures

Name	Time	Method
Compliance with AMMA use	6 months	Patient-reported questionnaire, including yes/no answers and description of the effectiveness and clarity of the training provided
Experience of AMMA use	6 months	Patient-reported questionnaire, including questions on a 1 to 4 scale, where 1 is not at all and 4 is very much, regarding ease of product setup and use in the clinic, during the ride home and at home
Symptoms associated with AMMA use	6 months	Patient-reported questionnaire, including questions on a 1 to 4 scale, where 1 is not at all and 4 is very much, regarding amount of hair loss and the impact of any hair loss on daily activities

Trial Locations

Locations (1)

White Plains Hospital; 🇺🇸 White Plains, New York, United States