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

NCT05365243 | Withdrawn FDA Device

• 1 other identifier: WPH 2201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Compliance with AMMA use

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

  6 months

• Experience of AMMA use

  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

  6 months

• Symptoms associated with AMMA use

  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

  6 months

Study Arms (1)

Interventional

EXPERIMENTAL

All patients will use AMMA

Device: AMMA Portalbe Scalp Cooling System

Interventions

AMMA Portalbe Scalp Cooling System 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.

Interventional

Eligibility Criteria

• Age: 21 Years+
• Gender Eligibility Details: Breast and gynecologic cancers
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cooler Heads Care Inc.: lead

Study Sites (1)

White Plains Hospital

White Plains, New York, 10601, United States

Location

MeSH Terms

Conditions

Alopecia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases

Study Officials

• Kate Dilligan

  Cooler Heads Care Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: August 15, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)