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

NCT ID: NCT05365243

Last Updated: 2023-08-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2023-09-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Interventional

All patients will use AMMA

Group Type: EXPERIMENTAL

AMMA Portalbe Scalp Cooling System

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cooler Heads Care Inc.

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kate Dilligan

Role: STUDY_DIRECTOR

Cooler Heads Care Inc.

Locations

White Plains Hospital

White Plains, New York, United States

Countries

United States

Other Identifiers

WPH 2201

Identifier Type: -

Identifier Source: org_study_id