Clinical Trials Logo
  1. Home
  2. Alopecia
  3. NCT04764357

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

Alopecia Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

Participants receiving cooling cap therapy will receive scalp hypothermia as delivered by the scalp cooling system and as per the manufacturers recommendations. 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. A trained study staff member will be present to place the cool cap on the participant, ensure proper fit, begin the cooling process, and ensure functionality. The bedside nurse on the inpatient unit will monitor the participants during the duration of cool cap therapy while also receiving chemotherapy infusion. A trained study team member will be available for any questions or issues that may arise during this time. When the participant is ready to remove the cooling cap a trained study team member will return to shut off the device, remove the cap, and assess the participant. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04764357
Study type Interventional
Source St. Jude Children's Research Hospital
Contact Deena Levine, MD
Phone 866-278-5833
Email referralinfo@stjude.org
Status Recruiting
Phase N/A
Start date June 4, 2021
Completion date December 2025
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04953416 - Fractional Non-ablative Laser for the Treatment of Hair Loss N/A
Completed NCT01929330 - Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers Phase 1
Recruiting NCT05213936 - Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color N/A
Completed NCT02919735 - Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN) Phase 2
Recruiting NCT02591823 - Hair Fall in Patients on Low Dose Methotrexate N/A
Enrolling by invitation NCT01651689 - Hair Counts From Vertical and Horizontal Sections of Scalp Biopsy SPecimens in Thai Population With Alopecia N/A
Completed NCT01189279 - Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia Phase 1
Recruiting NCT01111981 - Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia Phase 4
Terminated NCT01385839 - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata N/A
Active, not recruiting NCT03382184 - Fractional Photothermolysis for Hair Follicle Induction Early Phase 1
Not yet recruiting NCT05544448 - In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases N/A
Completed NCT03689452 - The Effect of Platelet Rich Plasma on Non-scarring Alopecia N/A
Completed NCT06409650 - To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia Phase 2
Recruiting NCT00801086 - Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain Phase 2
Completed NCT06095739 - Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002 N/A
Completed NCT05587699 - The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A Phase 1
Completed NCT03351322 - ENERGI-F701 for Female Hair Loss Treatment Phase 2
Terminated NCT02935569 - Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy N/A
Completed NCT01590238 - Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM) Phase 3
Not yet recruiting NCT01557491 - Hair Regrowth After Bicoronal Incision N/A