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Cold Cap Therapy for Chemotherapy-Induced Hair Loss in Children

N/A
Recruiting
Led By Deena Levine, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients receiving specific drugs known to cause complete alopecia
Patients receiving a chemotherapeutic agent likely to cause alopecia
Must not have
Patients receiving a chemotherapeutic agent for a hematologic malignant/neoplastic condition
Patients with cold agglutinin disease or cold urticaria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks +/- 2 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if the Paxman scalp cooling device is safe and effective in preventing hair loss in pediatric patients receiving chemotherapy for non-cancerous conditions or solid tumors.

Who is the study for?
This trial is for pediatric patients at least 7 years old with a head circumference of 50 cm or more, who are receiving chemotherapy likely to cause hair loss due to non-malignant conditions like Sickle Cell Disease or solid tumors (excluding brain tumors). It's not for those with past adverse reactions to scalp cooling, certain cold-related diseases, active scalp infections, or high risk of brain/scalp metastasis.
What is being tested?
The study tests the Paxman Scalp Cooling System's ability to prevent hair loss in children undergoing chemotherapy. Participants will use this device and undergo alopecia assessments and complete questionnaires about their experience as part of the research.
What are the potential side effects?
While specific side effects aren't listed for the cooling system, potential risks may include discomfort from the cold, headaches during treatment sessions, and possible skin issues on the scalp.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking medication that has caused complete hair loss.
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I am on chemotherapy that may cause hair loss.
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I am at least 7 years old.
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I have either a non-cancerous condition like Sickle Cell or a solid tumor (not in the brain).
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My head circumference is 50 cm or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently receiving chemotherapy for blood cancer.
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I have cold agglutinin disease or cold urticaria.
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I do not have an active scalp infection.
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I have cancer that has spread to my brain or scalp, or it's likely to.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks +/- 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks +/- 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility of the scalp cooling device
Safety of the scalp cooling device as descripted by CTCAE

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cooling Cap TherapyExperimental Treatment3 Interventions
Participants receiving cooling cap therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paxman Scalp Cooling System
2018
N/A
~130

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,305,441 Total Patients Enrolled
Deena Levine, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

Paxman Scalp Cooling System (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04764357 — N/A
~15 spots leftby Dec 2026
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