NCT05961215Completed
Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma
IIT2023-03-Vescio-ColdCap: Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma
Source: ClinicalTrials.gov · Last updated 27 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 18 Jul 2023
- Start date
- 10 Aug 2023
- Primary completion date
- 1 Nov 2024
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Multiple myeloma
- NCT number
- NCT05961215
What you commit to
- Study type: Interventional
- Participants enrolled: 31
- From 10 Aug 2023 to the primary completion date, 1 Nov 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior or current use of any scalp cooling treatment
- Medical History and Concurrent Diseases: Reynaud's disease, Cold sensitivity, Cold agglutinin disease, Cryoglobulinemia, Cryofibrinogenemia
- Current use of any other investigational agents
Other illness
- 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.
Other
- Hair covering \< 75% of the scalp on physical exam at screening visit.
- 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
- Current use of oxaliplatin
- Contraindication to melphalan
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.