Infections

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Respiratory Tract Infections

Alopecia

Alopecia Areata

Hypotrichosis

Hair Diseases

Skin Diseases

Pathological Conditions, Anatomical

Participants receiving cooling cap therapy

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.

Paxman Scalp Cooling System

Photographs of the hair will be taken before initiation of chemotherapy (baseline) and at a visit 4 weeks (3-6 week window) after the last dose of chemotherapy for those being treated for a non-cancerous condition. Patient with solid tumors will have photographic documentation at baseline, 2-5 weeks after every 2 cycles of chemotherapy, and at end of study (approximately 4 weeks following the last chemotherapy treatment with a range of 3-6 weeks).

Alopecia Assessments

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

Patient Reported Outcomes Questionnaires

Deena Levine, MD

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.

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

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

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

Proportion or Number of Patients who experience at least one grade 3 or 4 adverse events based on CTCAE when wearing the scalp cooling device.

Proportion of eligible participants who can tolerate at least 70% of the planned scalp cooling therapy. Feasibility will be established if 50% or greater of eligible patients can tolerate at least 70% of the planned scalp cooling therapy and opt to participate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors	NCT04764357	Alopecia	Paxman Scalp Co... Alopecia Assess... Patient Reporte...	7 Years -	St. Jude Children's Research Hospital
Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors	NCT04764357	Alopecia	Paxman Scalp Co... Alopecia Assess... Patient Reporte...	7 Years -	St. Jude Children's Research Hospital

Spots Global Cancer Trial Database for patient reported outcomes questionnaires