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Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Penguin Cold Cap
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18 years ECOG performance status ≤2 Confirmed multiple myeloma diagnosis Hair covering ≥75% of scalp on physical exam at screening visit Planning to undergo SOC high-dose chemotherapy with melphalan (dose to be used = 140 - 200 mg/m2 (with rounding per CSMC guidelines)) followed by an autologous peripheral blood stem cell transplant. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: Prior or current use of any scalp cooling treatment Hair covering < 75% of the scalp on physical exam at screening visit. Medical History and Concurrent Diseases: Reynaud's disease, Cold sensitivity, Cold agglutinin disease, Cryoglobulinemia, Cryofibrinogenemia Current spinal or neck injury that may interfere with the subject's participation for the full duration of the study, in the opinion of the treating investigator Skin conditions such as psoriasis, eczema, malignancy, or other condition on the scalp that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. Current use of oxaliplatin Current use of any other investigational agents Contraindication to melphalan

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Penguin Cold Cap

Arm Description

Patients will receive Penguin cold cap: 60 minutes prior to melphalan infusion and continue for 5 hours after melphalan infusion start time, for a total of 6 hours, on Days -2 and -1.

Outcomes

Primary Outcome Measures

Change in development of hair loss
Change in development of hair loss will be defined as < 50% hair loss (according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5, Grade 0 or 1) in 75% of patients treated.

Secondary Outcome Measures

Patient determined decision of scalp cooling benefit
Patient determined decision of scalp cooling benefit will be measured by Scalp Cooling Questionnaire, a homegrown scale ranging from no benefit to substantial benefit, with higher scores representing a better outcome.

Full Information

First Posted
July 18, 2023
Last Updated
July 27, 2023
Sponsor
Cedars-Sinai Medical Center
Collaborators
Penguin Cold Caps
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1. Study Identification

Unique Protocol Identification Number
NCT05961215
Brief Title
Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma
Official Title
IIT2023-03-Vescio-ColdCap: Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
Penguin Cold Caps

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This pilot study of scalp cooling with Penguin cold caps will examine the effectiveness of scalp cooling to reduce the development of hair loss in 30 participants with multiple myeloma undergoing high-dose chemotherapy with melphalan and autologous peripheral blood stem cell transplant at Cedars-Sinai Medical Center. The investigators will also assess the potential impact of hair loss versus the discomfort and inconvenience of the scalp cooling procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

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
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Penguin Cold Cap
Arm Type
Experimental
Arm Description
Patients will receive Penguin cold cap: 60 minutes prior to melphalan infusion and continue for 5 hours after melphalan infusion start time, for a total of 6 hours, on Days -2 and -1.
Intervention Type
Device
Intervention Name(s)
Penguin Cold Cap
Intervention Description
Penguin cold cap: administered 60 minutes prior to melphalan infusion and continue for 5 hours after melphalan infusion start time, for a total of 6 hours, on Days -2 and -1.
Primary Outcome Measure Information:
Title
Change in development of hair loss
Description
Change in development of hair loss will be defined as < 50% hair loss (according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5, Grade 0 or 1) in 75% of patients treated.
Time Frame
From the start of study treatment (Day -2) until Day 30.
Secondary Outcome Measure Information:
Title
Patient determined decision of scalp cooling benefit
Description
Patient determined decision of scalp cooling benefit will be measured by Scalp Cooling Questionnaire, a homegrown scale ranging from no benefit to substantial benefit, with higher scores representing a better outcome.
Time Frame
At Day 0 and Day 90.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 years ECOG performance status ≤2 Confirmed multiple myeloma diagnosis Hair covering ≥75% of scalp on physical exam at screening visit Planning to undergo SOC high-dose chemotherapy with melphalan (dose to be used = 140 - 200 mg/m2 (with rounding per CSMC guidelines)) followed by an autologous peripheral blood stem cell transplant. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: Prior or current use of any scalp cooling treatment Hair covering < 75% of the scalp on physical exam at screening visit. Medical History and Concurrent Diseases: Reynaud's disease, Cold sensitivity, Cold agglutinin disease, Cryoglobulinemia, Cryofibrinogenemia Current spinal or neck injury that may interfere with the subject's participation for the full duration of the study, in the opinion of the treating investigator Skin conditions such as psoriasis, eczema, malignancy, or other condition on the scalp that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. Current use of oxaliplatin Current use of any other investigational agents Contraindication to melphalan
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trial Navigator
Phone
3104232133
Email
cancer.trial.info@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Vescio, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Navigator
Phone
310-423-2133
Email
cancer.trial.info@cshs.org
First Name & Middle Initial & Last Name & Degree
David Oveisi, MD
First Name & Middle Initial & Last Name & Degree
Robert Vescio, MD

12. IPD Sharing Statement

Learn more about this trial

Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma

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