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

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Feb 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying whether a special cooling device, called the Paxman scalp cooling device, can help prevent hair loss in children and young adults who are receiving chemotherapy for non-cancerous conditions or solid tumors. Hair loss, known as alopecia, can be a distressing side effect of certain chemotherapy drugs, and the goal of this study is to see if using this cooling device is safe and effective for young patients undergoing treatment.

To be eligible for the study, participants must be at least 7 years old, have a head circumference of 50 cm or larger, and be receiving chemotherapy likely to cause hair loss for either a non-malignant condition (like Sickle Cell Disease) or a solid tumor (not involving the brain). Throughout the trial, participants will use the cooling device during their chemotherapy sessions and the study will track how well it works in reducing hair loss. It's important to note that not everyone will qualify, as certain health conditions or past experiences with the device could exclude them from participation.

Gender

ALL

Eligibility criteria

• 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