Using cold cap therapy to prevent hair loss in children undergoing chemotherapy
COOLCAP Pilot Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors
This study is testing if a cold cap can help children keep their hair while they receive chemotherapy for cancer and other conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 7 Years and up |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | methotrexate, cyclophosphamide, doxorubicin, chemotherapy |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT04764357 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients receiving chemotherapy known to cause hair loss for non-malignant conditions or solid tumors.
Not a fit: Patients receiving chemotherapy regimens that are unlikely to cause alopecia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of hair loss in children undergoing chemotherapy, improving their quality of life.
How similar studies have performed: Previous studies have shown promising results with scalp cooling devices in preventing hair loss during chemotherapy, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Memphis, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.