Actively Recruiting

Phase Not Applicable
Age: 7Years +
All Genders
NCT04764357

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

338 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is being done to see if the Paxman scalp cooling device can prevent hair loss in pediatric patients receiving chemotherapy for non-cancerous conditions or solid tumors. Primary Objective * To assess the safety and feasibility of the use of a scalp cooling device in pediatric and young adult patients receiving chemotherapy for non-malignant conditions and solid tumors. Exploratory Objectives * To assess the incidence and intensity of chemotherapy induced hair loss in patients receiving chemotherapy for non-malignant conditions and solid tumors who have used a scalp cooling device.

CONDITIONS

Official 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

Age: 7Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Receiving chemotherapy known to possibly cause hair loss
  • Diagnosed with a non-malignant condition like Sickle Cell Disease or Aplastic Anemia, or diagnosed with a solid tumor (excluding brain tumors)
  • At least 7 years old
  • Head circumference of 50 cm or greater
Not Eligible

You will not qualify if you...

  • Receiving chemotherapy for blood-related cancers
  • Having brain or scalp tumors, scalp metastasis, or high risk of brain or scalp metastasis
  • Considered unfit for the study by the doctor or primary care team
  • History of adverse reaction to the Paxman scalp cooling device
  • Having cold agglutinin disease or cold urticaria
  • Unable or unwilling to provide informed consent
  • Having an active scalp infection or infestation at enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

D

Deena Levine, MD

CONTACT

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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