NCT05365243

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Cooler Heads Care Inc. · Other Government
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alopecia
• Chemotherapy-induced Alopecia
• Hair Loss
• Breast Cancer
• Gynecologic Cancer

Interventions

Type	Name	Description
DEVICE	AMMA Portalbe Scalp Cooling System	AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center and at home and is intended for use by patients who are undergoing chemotherapy treatment and who want to reduce the likelihood of chemotherapy-induced alopecia.

Timeline

• Start date: 2022-08-15
• Primary completion: 2023-06-30
• Completion: 2023-09-30
• First posted: 2022-05-09
• Last updated: 2023-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study