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Trial Title:
Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma
NCT ID:
NCT05961215
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Penguin Cold Cap
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.
Arm group label:
Penguin Cold Cap
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars-Sinai Medical Center
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Start date:
August 10, 2023
Completion date:
June 2025
Lead sponsor:
Agency:
Cedars-Sinai Medical Center
Agency class:
Other
Collaborator:
Agency:
Penguin Cold Caps
Agency class:
Other
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05961215
