AlopeciaNCT04764357
Study Of Cold Cap Therapy For Prevention of Hairloss in Pediatric Patients Receiving Chemotherapy For Non-Malignant Indications and Solid Tumors
A study testing Paxman Scalp Cooling System, Alopecia Assessments and Patient Reported Outcomes Questionnaires in people with Alopecia, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Alopecia
- What is being tested?
- Paxman Scalp Cooling System, Alopecia Assessments and Patient Reported Outcomes Questionnaires
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2021to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Deena Levine, MD, 888-226-4343, referralinfo@stjude.org
Deena Levine, MD
About this study
Official title: 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 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.
Read the detailed description
Participants receiving cooling cap therapy will receive scalp hypothermia as delivered by the scalp cooling system and as per the manufacturers recommendations. Scalp cooling will begin at least 30-45 minutes prior to administration of each chemotherapy (45 minutes for those with thick or coarse hair types). Scalp temperature will be maintained at +3°C (37°F) throughout drug administration and for at least 120-180 minutes after discontinuing the infusion.
A trained study staff member will be present to place the cool cap on the participant, ensure proper fit, begin the cooling process, and ensure functionality. The bedside nurse on the inpatient unit will monitor the participants during the duration of cool cap therapy while also receiving chemotherapy infusion. A trained study team member will be available for any questions or issues that may arise during this time. When the participant is ready to remove the cooling cap a trained study team member will return to shut off the device, remove the cap, and assess the participant.
- Conditions
- Alopecia
- Being tested
- Paxman Scalp Cooling System, Alopecia Assessments, Patient Reported Outcomes Questionnaires
- Keywords
- Alopecia, Hair loss, Cooling, Scalp, Non-malignant disorders
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paxman Scalp Cooling SystemDevice
Scalp cooling will begin at least 30-45 minutes prior to administration of each chemotherapy (45 minutes for those with thick or coarse hair types). Scalp temperature will be maintained at +3°C (37°F) throughout drug administration and for at least 120-180 minutes after discontinuing the infusion. Scalp cooling will occur with each dose of chemotherapy.
Alopecia AssessmentsOther
Photographs will be taken prior to the use of the scalp cooling system and once at the end of the study. Patients with solid tumors will have additional photographs taken after every 2 cycles of chemotherapy.
Patient Reported Outcomes QuestionnairesOther
Also called Surveys
- Selected questions from NCI PRO-CTCAE™, Chemotherapy-Induced Alopecia Distress Scale (CADS), and PediQUEST Memorial Symptom Assessment Scale, at the following time points: baseline, after every 2 cycles of chemotherapy, 4 week follow up and end of study.
- Tolerability Questionnaire each time the cooling cap is used and at the end of study
| Study group | Role | What they receive |
|---|---|---|
| Cooling Cap Therapy | Experimental | Participants receiving cooling cap therapy Receives: Device: Paxman Scalp Cooling System; Other: Alopecia Assessments; Other: Patient Reported Outcomes Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the scalp cooling device as descripted by CTCAE
Proportion or Number of Patients who experience at least one grade 3 or 4 adverse events based on CTCAE when wearing the scalp cooling device.
Measured: 4 weeks +/- 2 weeks
Feasibility of the scalp cooling device
Proportion of eligible participants who can tolerate at least 70% of the planned scalp cooling therapy. Feasibility will be established if 50% or greater of eligible patients can tolerate at least 70% of the planned scalp cooling therapy and opt to participate.
Measured: 4 weeks +/- 2 weeks
Feasibility of the scalp cooling device
Feasibility will be assessed by evaluating the percentage of eligible patients who opt to receive Cool Cap therapy. Feasibility in this regard will have been achieved if 50% or more of eligible patients opt to receive Cool Cap therapy.
Measured: At the 2 year study time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start4 Jun 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deena Levine, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04764357
- Sponsor's protocol ID
- COOLCAP
- Other IDs
- NCI-2022-06012
- Status last verified
- Apr 2026
- First submitted
- 17 Feb 2021
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.