Study of Cold Cap Therapy for Hair Loss in Pediatric Patients
This study is looking at whether the Paxman Scalp Cooling System can help prevent hair loss (alopecia) in children and young adults receiving chemotherapy. This includes patients with non-cancerous conditions or solid tumors. Researchers want to see if the cooling system is safe and practical to use. They will also observe how much hair loss occurs in patients using the device. The study is currently unclear about its recruitment status and aims to enroll 40 participants aged 7 and older who are receiving chemotherapy known to cause hair loss.
- Study design
- This is an interventional study planning to enroll 40 participants. The phase of the study is not specified.
- What's involved
- You would receive scalp cooling before, during, and after each chemotherapy session. You would also have photographs taken and complete questionnaires at various times throughout the study and at follow-up.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety and feasibility of the device will be measured at 4 weeks +/- 2 weeks, and feasibility will also be measured at the 2-year study time point.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Deena Levine, MD · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital
Who to contact
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What this trial measures
- Safety of the scalp cooling device as descripted by CTCAE4 weeks +/- 2 weeks
Proportion or Number of Patients who experience at least one grade 3 or 4 adverse events based on CTCAE when wearing the scalp cooling device.
- Feasibility of the scalp cooling device4 weeks +/- 2 weeks
Proportion of eligible participants who can tolerate at least 70% of the planned scalp cooling therapy. Feasibility will be established if 50% or greater of eligible patients can tolerate at least 70% of the planned scalp cooling therapy and opt to participate.
- Feasibility of the scalp cooling deviceAt the 2 year study time point
Feasibility will be assessed by evaluating the percentage of eligible patients who opt to receive Cool Cap therapy. Feasibility in this regard will have been achieved if 50% or more of eligible patients opt to receive Cool Cap therapy.