First Non-Cancer Scalp Cooling Study for the Prevention of Chemotherapy-induced Hair Loss in Pediatric Patients
An observational, prospective pilot study will see the use of a Paxman Scalp Cooling System for the first time in such research.
The research “Pilot Study of Cold Cap Therapy for Prevention of Hair loss in Pediatric Patients Receiving Chemotherapy for Non-Malignant Indications” is not only the first study undertaken with Paxman in pediatric patients, but also the first time scalp cooling has been investigated as a therapy for the prevention of hair loss for patients receiving chemotherapy for non-malignant indications.
The negative impact of chemotherapy-induced alopecia (CIA) on a patient’s body image, self-esteem and the associated reduction in social interaction is widely documented and is no different for children and young adults.
“We are delighted to be exploring this area of scalp cooling research which aligns with Paxman’s goals for access to scalp cooling. We will continue to strive to ensure that every applicable patient, whatever their age and no matter where in the world or what their financial position, has the opportunity to maintain a sense of normalcy by keeping their hair through chemotherapy treatment. The collaborative work such as this trial can only help us achieve this,” commented Richard Paxman, CEO.
The primary aim of the study is to assess the safety and feasibility of the use of scalp cooling in pediatric and young adult patients receiving chemotherapy for non-malignant disorders. Comparisons will be made of hair loss experienced by the scalp-cooled patients receiving chemotherapy and those patients who do not use scalp cooling during their chemotherapy treatment.
The incidence and intensity of chemotherapy induced hair loss in patients receiving chemotherapy for non-malignant conditions who have used a scalp-cooling device will also be assessed.
High dose conditioning chemotherapy and subsequent hematopoietic stem cell transplant (HSCT) has been associated with permanent chemotherapy induced alopecia. The incidence of permanent alopecia ranges from 0.9% to 43% in adults and 24% in pediatric patients.
The recruitment of up to 40 participants will begin in mid-March with an anticipated primary end date of December 2024. Conclusion of the study is expected by the end of 2025.
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