Actively Recruiting
COOLCAP Pilot Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors
Led by St. Jude Children's Research Hospital · Updated on 2026-05-01
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether the Paxman scalp cooling device can prevent hair loss in children and young adults receiving chemotherapy for non-cancerous conditions or solid tumors. The study focuses on assessing the safety and feasibility of scalp cooling in these patients and explores how often and how severe chemotherapy-induced hair loss occurs when using the cooling device. Participants will receive scalp cooling starting 30 to 45 minutes before each chemotherapy session, with the cooling maintained throughout the drug infusion and continuing for 120 to 180 minutes afterward. A trained staff member will apply, monitor, and remove the cooling cap, ensuring the scalp temperature stays at about 3°C (37°F). The therapy will be provided with every chemotherapy dose, following the manufacturer's instructions. During the study, participants will have photographs taken to assess hair loss, with additional photos for those with solid tumors after every two chemotherapy cycles. They will also complete questionnaires about symptoms and tolerability at different points, including baseline, during treatment, and follow-ups. Safety and feasibility will be closely monitored up to two years, and study involvement will last according to the chemotherapy schedule and follow-up assessments.
CONDITIONS
Brief Title
Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Receiving chemotherapy likely to cause hair loss, including specific cytotoxic agents
- Diagnosed with a non-malignant condition or a solid tumor (non-brain tumor)
- Age 7 years or older
- Head circumference of 50 cm or greater
You will not qualify if you...
- Receiving chemotherapy for a blood-related cancer
- Presence of brain or scalp tumors, scalp metastasis, or high risk of such metastasis
- Unfit for study based on investigator or primary team opinion
- Previous adverse reaction to the Paxman scalp cooling device
- Cold agglutinin disease or cold urticaria
- Unable or unwilling to provide informed consent
- Active scalp infection or infestation at enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of chemotherapy treatment
Participants receive scalp hypothermia therapy using the Paxman Scalp Cooling System during each chemotherapy infusion to help prevent hair loss. Scalp cooling starts 30-45 minutes before chemotherapy and continues for 120-180 minutes after infusion ends, with trained staff applying and monitoring the cooling cap.
A visit each time chemotherapy and scalp cooling are administered
Duration - Duration of chemotherapy treatment plus 4 weeks follow-up
Photographs to assess hair condition are taken before starting scalp cooling, after every 2 chemotherapy cycles for participants with solid tumors, and at the end of the study. Patient-reported outcome questionnaires on tolerability and alopecia distress are collected at baseline, after every 2 cycles, at a 4-week follow-up, and at study end.
Visits aligned with every 2 chemotherapy cycles, plus baseline, 4-week follow-up, and end-of-study visits
Duration - 4 weeks after chemotherapy, with additional assessment up to 2 years
Participants are monitored for safety and feasibility of the scalp cooling device for 4 weeks after completing chemotherapy, with additional long-term feasibility assessment at the 2-year study time point.
1 visit at 4 weeks post-treatment and 1 visit at 2 years
Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
D
Deena Levine, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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