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

• Sponsor: Cooler Heads Care Inc. (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05365243
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 13.5
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alopecia; Chemotherapy-induced Alopecia; Hair Loss; Breast Cancer; Gynecologic Cancer	Device: AMMA Portalbe Scalp Cooling System	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System
• Anticipated Study Start Date: Aug 15, 2022
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional All patients will use AMMA	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.

Outcome Measures

Primary Outcome Measures

1. Compliance with AMMA use [6 months]

   Patient-reported questionnaire, including yes/no answers and description of the effectiveness and clarity of the training provided

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	White Plains Hospital	White Plains	New York	United States	10601

Sponsors and Collaborators

• Cooler Heads Care Inc.

Investigators

• Study Director: Kate Dilligan, Cooler Heads Care Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cooler Heads Care Inc.
• ClinicalTrials.gov Identifier: NCT05365243
• Other Study ID Numbers: WPH 2201
• First Posted: May 9, 2022
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Alopecia; Alopecia Areata

Study Results

No Results Posted as of Aug 1, 2022