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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks +/- 2 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of the scalp cooling device
Safety of the scalp cooling device as descripted by CTCAE

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
428 Previous Clinical Trials
5,306,573 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical trial currently have open enrollment?

"Affirmative. The clinical trial page on clinicaltrials.gov indicates that this research, which was initially posted to the platform on June 4th 2021, is presently recruiting participants. 40 people need to be sourced from 1 medical centre."

Answered by AI

How many people are participating in this clinical trial at its highest capacity?

"Affirmative. Clinicaltrials.gov indicates that this medical trial, first posted on June 4th 2021, is presently recruiting patients. 40 participants need to be enrolled at a single site."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What site did they apply to?
St. Jude Children's Research Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have tried vitamins and hair products for my baldness but nothing has worked.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors
2021. "Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04764357.
All > Androgenetic Alopecia > Alopecia
~7 spots leftby Dec 2024
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