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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT04764357
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
7 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paxman Scalp Cooling System — DEVICE
    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.
  • Alopecia Assessments — OTHER
    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.
  • Patient Reported Outcomes Questionnaires — OTHER
    * 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

Study Details

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.

Key Dates

Start date
Jun 4, 2021
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Cooling Cap Therapy
    Participants receiving cooling cap therapy

Primary Outcome Measure

Safety of the scalp cooling device as descripted by CTCAE [ Time Frame: 4 weeks +/- 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Deena Levine, MD
[email protected]
888-226-4343
Deena Levine, MD (PRINCIPAL_INVESTIGATOR)

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By research site
St. Jude Children's Research Hospital· Memphis, TN

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