Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Alopecia

Alopecia Areata

Breast Diseases

Skin Diseases

Hypotrichosis

Hair Diseases

Pathological Conditions, Anatomical

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

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

AMMA Portalbe Scalp Cooling System

Chris Schultz, BS

Kate Dilligan

The purpose of this prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer. Additionally, the purpose is also to assess the safety, tolerability and compliance, quality of life, and satisfaction with hair preservation after CT treatment.

This is a prospectively enrolling, post-market, on-label study to assess the ability of the AMMA PSCS to prevent hair loss in women receiving CT for early-stage breast cancer, and to assess the safety, tolerability and compliance, patient quality of life, and satisfaction with hair after treatment. Female patients at least 21 years of age with stage I, II, or III breast cancer who are receiving a taxane-containing CT regimen that is scheduled to be completed within six months will be identified and data from the electronic health record (EHR) as well as prospective data will be collected.

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 at least 2.5 hours after chemotherapy. Scalp photos will be obtained at baseline and after the last chemotherapy treatment.

Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss

A Post-market Multi-center Prospective Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss in Women Receiving Specific Chemotherapy Regimens for Breast Cancer Stages I-III.

To evaluate hair loss as assessed by the investigator at 3 weeks (±1 week) after the completion of the last CT treatment/infusion visit using the Common Terminology Criteria for Adverse Events (CTCAE) post-treatment, by photographs, compared to baseline photographs.

To assess safety of the AMMA PSCS based on the occurrence of device-related adverse events, occurrence of scalp changes determined by physical examination, and patient symptoms with use of the PSCS.

Occurrence of scalp changes in patients during and after use of the AMMA PSCS.

Patient symptoms reported during use of the AMMA PSCS as recorded by a symptom survey following each infusion session.

Subject's tolerability of AMMA PSCS treatment demonstrated by responses to questions related to tolerability.

Patient assessment of hair loss as recorded in the Alopecia Self-Report Survey at post-treatment follow-up according to the following scale: \<50% of normal for the patient, or ≥50% hair loss.

Patient satisfaction and QoL as assessed by the BIS at baseline and posttreatment follow-up.

The 10-item Body Image Scale was developed by Hopwood et al. in 2001 to measure affective, behavioral, and cognitive body image symptoms. Patients can indicate body image symptoms on a 4-point scale (0 "not at all" to 3 "very much"). The total score ranges from 0 to 30 and can be calculated by summing up the 10 items. A higher score means a higher level of body image disturbance

Patient satisfaction and QoL as assessed by the EORTC's QLQ-BR23 at baseline and post-treatment follow-up.

All scores are linearly transformed to a 0 to 100 scale. A high or healthy level of functioning is represented by a high functional score. A high QOL is represented by a high score for global health status or QOL. More severe symptoms or problems are represented by high symptom scores or items.

Device success is defined as ability to set up and use the AMMA device as instructed. This will be measured for each treatment and then for all treatments. If a study subject does not complete one or more of the CT visits, that does not constitute a device failure.

Cooler Heads Care Inc.

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.

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.

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.

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss	NCT05484973	Alopecia Chemotherapy-in... Hair Loss Breast Cancer	AMMA Portalbe S...	21 Years -	Cooler Heads Care Inc.
A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads	NCT05365243	Alopecia Chemotherapy-in... Hair Loss Breast Cancer Gynecologic Can...	AMMA Portalbe S...	21 Years -	Cooler Heads Care Inc.
A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads	NCT05365243	Alopecia Chemotherapy-in... Hair Loss Breast Cancer Gynecologic Can...	AMMA Portalbe S...	21 Years -	Cooler Heads Care Inc.

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