Back to resultsA Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads
Primary Purpose
Alopecia, Chemotherapy-induced Alopecia, Hair Loss
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AMMA Portalbe Scalp Cooling System
Sponsored by
About this trial
This is an interventional supportive care trial for Alopecia
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
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
Sites / Locations
- White Plains Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Interventional
Arm Description
All patients will use AMMA
Outcomes
Primary Outcome Measures
Compliance with AMMA use
Patient-reported questionnaire, including yes/no answers and description of the effectiveness and clarity of the training provided
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
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05365243
Brief Title
A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads
Official Title
A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Single-site study, site was unable to participate
Study Start Date
August 15, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cooler Heads Care Inc.
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia, Chemotherapy-induced Alopecia, Hair Loss, Breast Cancer, Gynecologic Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional
Arm Type
Experimental
Arm Description
All patients will use AMMA
Intervention Type
Device
Intervention Name(s)
AMMA Portalbe Scalp Cooling System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compliance with AMMA use
Description
Patient-reported questionnaire, including yes/no answers and description of the effectiveness and clarity of the training provided
Time Frame
6 months
Title
Experience of AMMA use
Description
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
Time Frame
6 months
Title
Symptoms associated with AMMA use
Description
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
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Breast and gynecologic cancers
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Dilligan
Organizational Affiliation
Cooler Heads Care Inc.
Official's Role
Study Director
Facility Information:
Facility Name
White Plains Hospital
City
White Plains
State/Province
New York
ZIP/Postal Code
10601
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Pilot Study to Evaluate the Use of the AMMA Portable Scalp Cooling System From Cooler Heads
We'll reach out to this number within 24 hrs