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NCT04764357Recruiting

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

Source: ClinicalTrials.gov · Last updated 1 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
40 (estimated)
First submitted
17 Feb 2021
Start date
4 Jun 2021
Primary completion date
31 Dec 2026
Lead sponsor
St. Jude Children's Research Hospital
NCT number
NCT04764357

What you commit to

  • Study type: Interventional
  • Planned participants: 40
  • From 4 Jun 2021 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients receiving a chemotherapeutic agent for a hematologic malignant/neoplastic condition.
  • Patients with a previous history of adverse event associated with the Paxman scalp kit or scalp cooling device

Other illness

  • 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 with cold agglutinin disease or cold urticaria
  • Patients with an active infection/infestation of scalp at the time of study enrollment

Other

  • Patients who are unfit for the study based on the opinion of the primary investigator and/or the patient's primary team.
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent

Who the study is looking for

  • 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

Age in the registry: 7 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Jude Children's Research Hospital
Coordinator of this site? Confirm its status
MemphisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.