Using cold cap therapy to prevent hair loss in children undergoing chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of the Paxman scalp cooling device in preventing hair loss in pediatric patients receiving chemotherapy for non-malignant conditions and solid tumors. Participants will undergo scalp cooling starting 30-45 minutes before chemotherapy administration, with the cooling maintained throughout the treatment and for a period afterward. The study aims to assess both the safety and feasibility of this intervention, as well as the incidence and intensity of chemotherapy-induced hair loss among participants. A trained team will monitor the participants during the cooling process to ensure proper application and address any concerns.

Why it matters

Who can join: the full rules

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

Where it's running

• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Deena Levine, MD — St. Jude Children's Research Hospital
• Study coordinator: Deena Levine, MD
• Email: referralinfo@stjude.org
• Phone: 888-226-4343

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Alopecia Areata: looking at ferroptosis markers in blood

  This study tests whether levels of GPX4 and MDA in blood differ between people with alopecia areata and healthy controls.

  Recruiting Istanbul Training and Research Hospital · Istanbul, Cerrahpasa Mahallesi · NCT07733063

• Using scalp cooling to reduce chemotherapy hair loss and protect quality of life for breast cancer patients

  This trial will test whether the PAXMAN scalp cooling system helps adults with stage I–III breast cancer keep more hair and feel better during anthracycline- or taxane-based chemotherapy.

  Recruiting Ballad Health · Kingsport, Tennessee · NCT07422376

• Autologous hair follicle secretome treatment for androgenic alopecia

  This will test whether injecting a person's own hair-follicle secretome into the scalp can help adults with androgenic alopecia grow thicker, denser hair.

  Recruiting Acorn Biolabs Inc. · West Hollywood, California · NCT07107841

• 6-month Chinese herbal treatment for hair loss and gray hair

  This 24-week trial will try two different herbal capsule formulas plus a hair tonic versus placebos to see if they help adults (18–60) with hair loss and some with gray hair.

  Recruiting Vita Green Pharmaceutical (H.K.) Ltd. · Xiangtan, Hunan · NCT06998680

• Using cryotherapy to prevent eyebrow and eyelash loss in breast cancer patients undergoing chemotherapy

  This study is testing whether cryotherapy can help breast cancer patients keep their eyebrows and eyelashes while they undergo chemotherapy.

  Recruiting at 2 sites University of Salamanca · Santander, Cantabria and 1 other locations · NCT06955702

• Registry for systemic treatments of alopecia areata

  This study is trying to see how well different systemic treatments work for people with moderate-to-severe alopecia areata, alopecia totalis, and alopecia universalis.

  Recruiting Erasmus Medical Center · Rotterdam · NCT06283316

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.