Back to resultsStudy to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
Primary Purpose
Alopecia, Chemotherapy-induced Alopecia, Hair Loss
Status
Not yet recruiting
Phase
Not Applicable
Locations
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 patients ≥ 21 years of age
- Documented diagnosis of breast cancer, stage I, II, or III
- A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent
- Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such as cyclophosphamide, or carboplatin Note: Targeted and/or hormonal therapies intended for use after completion of the taxane-containing CT regimen will not be considered part of the study treatment period, and the AMMA PSCS will not be used during the post-CT targeted and/or hormonal therapy period
- Plan to complete the current CT regimen within six months
- At least two years out from the last CT causing hair loss with complete recovery of hair
- Karnofsky17 performance status 80% or greater
- Willing and able to sign informed consent for this study
- Willing and able to complete all required study procedures
Exclusion Criteria:
- Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
- Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss, others
- A history of whole brain radiation
- Plans to use a CT regimen other than those specified in the inclusion criteria; specifically, a regimen not including paclitaxel or docetaxel or a regimen including an anthracycline (AC/T, EC/T, TAC, etc.)
- Hormone therapy concurrent with CT. Hormone therapy after CT is permitted
- Current and/or prior use of hair growth products, such as Nutrafol, minoxidil, and Keranique
- A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up
- History of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
- History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss
- Cold sensitivity
- Intercurrent life-threatening malignancy
- Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism
- History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
- Concurrent hematologic malignancy
- Participation in any other clinical investigation
- Concurrent treatment with any investigational agent
- Any reason the investigator does not believe the patient is a good candidate for the study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
All patients will use AMMA
Arm Description
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.
Outcomes
Primary Outcome Measures
Hair Loss
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.
Secondary Outcome Measures
Device-related adverse events
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.
Scalp changes
Occurrence of scalp changes in patients during and after use of the AMMA PSCS.
Patient symptoms
Patient symptoms reported during use of the AMMA PSCS as recorded by a symptom survey following each infusion session.
Subject's tolerability
Subject's tolerability of AMMA PSCS treatment demonstrated by responses to questions related to tolerability.
Patient assessment of hair loss
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 - Body Image Scale (BIS)
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 - European Organization for Research and Treatment (EORTC) QLQ-BR23
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05484973
Brief Title
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
March 1, 2025 (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
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.
Detailed Description
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.
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
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
99 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All patients will use AMMA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AMMA Portalbe Scalp Cooling System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hair Loss
Description
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.
Time Frame
3 Weeks
Secondary Outcome Measure Information:
Title
Device-related adverse events
Description
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.
Time Frame
3 Weeks
Title
Scalp changes
Description
Occurrence of scalp changes in patients during and after use of the AMMA PSCS.
Time Frame
3 Weeks
Title
Patient symptoms
Description
Patient symptoms reported during use of the AMMA PSCS as recorded by a symptom survey following each infusion session.
Time Frame
3 Weeks
Title
Subject's tolerability
Description
Subject's tolerability of AMMA PSCS treatment demonstrated by responses to questions related to tolerability.
Time Frame
3 Weeks
Title
Patient assessment of hair loss
Description
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.
Time Frame
3 Weeks
Title
Patient satisfaction and QoL - Body Image Scale (BIS)
Description
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
Time Frame
3 Weeks
Title
Patient satisfaction and QoL - European Organization for Research and Treatment (EORTC) QLQ-BR23
Description
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.
Time Frame
3 Weeks
Title
Device success
Description
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.
Time Frame
3 Weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Breast cancer
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients ≥ 21 years of age
Documented diagnosis of breast cancer, stage I, II, or III
A planned taxane-containing CT regimen in the adjuvant or neoadjuvant setting with curative intent
Concomitant agents may include trastuzumab, pertuzumab, or other CT agents such as cyclophosphamide, or carboplatin Note: Targeted and/or hormonal therapies intended for use after completion of the taxane-containing CT regimen will not be considered part of the study treatment period, and the AMMA PSCS will not be used during the post-CT targeted and/or hormonal therapy period
Plan to complete the current CT regimen within six months
At least two years out from the last CT causing hair loss with complete recovery of hair
Karnofsky17 performance status 80% or greater
Willing and able to sign informed consent for this study
Willing and able to complete all required study procedures
Exclusion Criteria:
Patients with female pattern baldness resembling picture I-3 or higher on the Savin scale
Autoimmune disease affecting hair; e.g. alopecia areata, systemic lupus with associated hair loss, others
A history of whole brain radiation
Plans to use a CT regimen other than those specified in the inclusion criteria; specifically, a regimen not including paclitaxel or docetaxel or a regimen including an anthracycline (AC/T, EC/T, TAC, etc.)
Hormone therapy concurrent with CT. Hormone therapy after CT is permitted
Current and/or prior use of hair growth products, such as Nutrafol, minoxidil, and Keranique
A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up
History of persistent grade 2 (or higher) alopecia induced by prior chemotherapeutic regimens
History of and/or current exposure to other agents, drugs, device, or procedure that may cause hair loss
Cold sensitivity
Intercurrent life-threatening malignancy
Evidence of untreated or poorly controlled hyperthyroidism or hypothyroidism
History or current diagnosis of any of the following: Cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia
Concurrent hematologic malignancy
Participation in any other clinical investigation
Concurrent treatment with any investigational agent
Any reason the investigator does not believe the patient is a good candidate for the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chris Schultz, BS
Phone
9715067552
Email
cschultz@ecr-inc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Dilligan
Organizational Affiliation
Cooler Heads Inc.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
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