MedTrace Logo

Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors

NCT04764357 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-05-01

No results posted yet for this study

Summary

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

Interventions

DEVICE

Paxman Scalp Cooling System

Scalp cooling will begin at least 30-45 minutes prior to administration of each chemotherapy (45 minutes for those with thick or coarse hair types). Scalp temperature will be maintained at +3°C (37°F) throughout drug administration and for at least 120-180 minutes after discontinuing the infusion. Scalp cooling will occur with each dose of chemotherapy.

OTHER

Alopecia Assessments

Photographs will be taken prior to the use of the scalp cooling system and once at the end of the study. Patients with solid tumors will have additional photographs taken after every 2 cycles of chemotherapy.

OTHER

Patient Reported Outcomes Questionnaires

* Selected questions from NCI PRO-CTCAE™, Chemotherapy-Induced Alopecia Distress Scale (CADS), and PediQUEST Memorial Symptom Assessment Scale, at the following time points: baseline, after every 2 cycles of chemotherapy, 4 week follow up and end of study. * Tolerability Questionnaire each time the cooling cap is used and at the end of study

Sponsors & Collaborators

Principal Investigators

  • Deena Levine, MD · St. Jude Children's Research Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-04
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04764357 on ClinicalTrials.gov