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

Recruiting now · Not applicable

Conditions studied: Alopecia

In brief

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 facts

Study ID: NCT04764357
Run by: St. Jude Children's Research Hospital
People needed: 40
Starts: 2021-06-04
Expected to finish: 2027-12-01
Last updated by the study team: 2026-05-01

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
Diagnosed with a non-malignant condition (such as Sickle Cell Disease or Aplastic Anemia) OR Diagnosed with a solid tumor (non-brain tumor)
Patients must be at least 7 years old
Patients should have a head circumference of 50 cm or greater

You may not qualify if…

Patients receiving a chemotherapeutic agent for a hematologic malignant/neoplastic condition.
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.)
Patients who are unfit for the study based on the opinion of the primary investigator and/or the patient's primary team.
Patients with a previous history of adverse event associated with the Paxman scalp kit or scalp cooling device
Patients with cold agglutinin disease or cold urticaria
Inability or unwillingness of research participant or legal guardian/representative to give written informed consent
Patients with an active infection/infestation of scalp at the time of study enrollment

Where it is running

St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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