Trial results for a pilot study investigating scalp cooling to prevent hair loss in patients with Multiple Myeloma were posted on ClinicalTrials.gov on 2025-10-27, indicating that 26 out of 30 participants using Penguin cold caps experienced reduced hair loss during stem cell transplantation.
Background
Multiple myeloma is a cancer of plasma cells, a type of white blood cell found in the bone marrow. Treatment often involves high-dose chemotherapy, such as melphalan, followed by autologous peripheral blood stem cell transplantation. While effective, this intensive chemotherapy regimen frequently leads to significant side effects, including severe hair loss (alopecia). Chemotherapy-induced alopecia can have a profound negative impact on a patient's quality of life, body image, and psychological well-being. Scalp cooling is a technique designed to reduce blood flow to the hair follicles during chemotherapy, thereby limiting the amount of chemotherapy drug that reaches the follicles and potentially preventing or minimizing hair loss.
Trial design
This completed pilot study, identified as Phase NA, enrolled 31 participants with Multiple Myeloma undergoing high-dose chemotherapy with melphalan and autologous peripheral blood stem cell transplant. The trial's primary aim was to examine the effectiveness of scalp cooling, specifically using Penguin cold caps, to reduce the development of hair loss. Investigators also assessed the potential impact of hair loss compared to the discomfort and inconvenience associated with the scalp cooling procedure. The study was conducted at Cedars-Sinai Medical Center.
Key results
The trial results focused on two main outcomes for participants using the Penguin Cold Cap:
- For the outcome titled "Change in Development of Hair Loss," out of 30 participants, 26 showed reduced hair loss, while 4 experienced hair loss.
- For the outcome titled "Patient Determined Decision of Scalp Cooling Benefit," the results showed a breakdown of patient decisions among 29 participants: 2 participants, 8 participants, 6 participants, and 13 participants.
What this means
The findings from this pilot study suggest that scalp cooling with Penguin cold caps can be an effective intervention for reducing hair loss in multiple myeloma patients undergoing high-dose chemotherapy and autologous stem cell transplantation. With 26 out of 30 participants experiencing reduced hair loss, the procedure demonstrates a positive impact on a common and distressing side effect of treatment. The data on patient-determined benefit also highlights the importance of patient perception regarding the procedure's value, despite potential discomfort. These results offer encouraging evidence for the use of scalp cooling to improve the quality of life for multiple myeloma patients during their treatment journey.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05961215, titled "Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma," were posted on 2025-10-27 on clinicaltrials.gov.