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

Not Applicable

Recruiting

• Conditions: Alopecia
• Interventions: Device: Paxman Scalp Cooling System; Other: Alopecia Assessments; Other: Patient Reported Outcomes Questionnaires

• Registration Number: NCT04764357
• Lead Sponsor: St. Jude Children's Research Hospital

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Study Start: 2021-06-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients receiving a chemotherapeutic agent likely to cause alopecia. Any patient receiving the following drugs may experience complete alopecia (dose and schedule dependent). If they are receiving such a drug for a non- malignant indication or solid tumor, they may be suitable for inclusion in the study and may benefit from the use of a scalp cooling device. Of the commonly used intravenous single cytotoxic agents, those most likely to cause complete alopecia (dose and schedule dependent) include alkylating agents (cyclophosphamide, ifosfamide, busulfan, thiotepa), antitumor antibiotics (dactinomycin, doxorubicin, epirubicin, idarubicin), antimicrotubule agents (paclitaxel, docetaxel, ixabepilone, eribulin), and topoisomerase inhibitors (etoposide, irinotecan). Alopecia is less common or incomplete with bleomycin, low-dose epirubicin or doxorubicin (especially <30 mg/m2), oral cyclophosphamide, fluorouracil, gemcitabine, melphalan, methotrexate, mitomycin, mitoxantrone, the platinums (oxaliplatin, cisplatin, and carboplatin), topotecan, and the vinca alkaloids. Antibody-drug conjugates are also associated with variable hair loss, which is agent specific.
2. Diagnosed with a non-malignant condition (such as Sickle Cell Disease or Aplastic Anemia) OR Diagnosed with a solid tumor (non-brain tumor)
3. Patients must be at least 7 years old
4. Patients should have a head circumference of 50 cm or greater

Exclusion Criteria

1. Patients receiving a chemotherapeutic agent for a hematologic malignant/neoplastic condition.
2. Patients with neoplasm of the brain or scalp, or present scalp metastasis, or high risk of metastatic disease to the brain or scalp (for example, neuroblastoma, melanoma or other skin malignancies, or patients who have had or are scheduled to undergo cranial irradiation.)
3. Patients who are unfit for the study based on the opinion of the primary investigator and/or the patient's primary team.
4. Patients with a previous history of adverse event associated with the Paxman scalp kit or scalp cooling device
5. Patients with cold agglutinin disease or cold urticaria
6. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
7. Patients with an active infection/infestation of scalp at the time of study enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cooling Cap Therapy	Patient Reported Outcomes Questionnaires	Participants receiving cooling cap therapy
Cooling Cap Therapy	Paxman Scalp Cooling System	Participants receiving cooling cap therapy
Cooling Cap Therapy	Alopecia Assessments	Participants receiving cooling cap therapy

Primary Outcome Measures

Name	Time	Method
Safety of the scalp cooling device as descripted by CTCAE	4 weeks +/- 2 weeks	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.
Feasibility of the scalp cooling device	At the 2 year study time point	Feasibility will be assessed by evaluating the percentage of eligible patients who opt to receive Cool Cap therapy. Feasibility in this regard will have been achieved if 50% or more of eligible patients opt to receive Cool Cap therapy.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States