Cold Cap Therapy for Chemotherapy-Induced Hair Loss in Children

Overseen By Deena Levine, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: St. Jude Children's Research Hospital

Must be taking: Chemotherapy

Disqualifiers: Brain neoplasm, Scalp metastasis, Cold agglutinin, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special cold cap can prevent hair loss in children and young adults undergoing chemotherapy for non-cancerous conditions or solid tumors. The main aim is to determine if the Paxman Scalp Cooling System (a type of cold cap therapy) is safe and practical for these patients. It also evaluates the effectiveness of the cooling cap in reducing hair loss during treatment. Children aged 7 or older, with a head circumference of 50 cm or more, and undergoing chemotherapy for certain conditions might be suitable candidates. As an unphased trial, this study provides a unique opportunity to enhance understanding of innovative methods for managing chemotherapy side effects.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on the use of a scalp cooling device during chemotherapy.

What prior data suggests that the Paxman scalp cooling device is safe for pediatric patients?

Research shows that the Paxman Scalp Cooling System is generally easy to use. In past studies, about 56% of users during chemotherapy did not need a hat or scarf due to minimal hair loss. This indicates the treatment is both effective and safe.

The device cools the scalp to help prevent hair loss from chemotherapy. Most patients report only mild side effects, such as a headache or feeling cold, which are usually manageable.

The Paxman system has undergone various trials and received approval for adults with cancer, reinforcing its safety. While this study focuses on children and young adults, existing data confirms its safety for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Paxman Scalp Cooling System because it offers a new way to combat chemotherapy-induced hair loss in children. Unlike traditional treatments that focus on managing hair loss after it occurs, this system works by cooling the scalp during chemotherapy sessions to reduce the likelihood of hair loss from the start. This cooling method helps to constrict blood vessels and reduce the amount of chemotherapy drugs reaching the hair follicles, potentially preserving hair. It’s a proactive approach that could significantly improve the quality of life for young patients undergoing chemotherapy.

What evidence suggests that the Paxman scalp cooling device is effective for preventing chemotherapy-induced hair loss in children?

Research has shown that the Paxman Scalp Cooling System, which participants in this trial will receive, can help prevent hair loss from chemotherapy. In one study, 53 out of 95 patients who used the cooling cap kept their hair, while none in the group without the cap did. Another study found that patients using the Paxman device, especially those receiving taxane-based treatments, preserved their hair better. Additionally, a large study reported that 89% of patients using this system successfully maintained their hair. This evidence suggests that the Paxman Scalp Cooling System effectively reduces hair loss caused by chemotherapy. ^{1 6 7 8 9}

Who Is on the Research Team?

Deena Levine, MD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for pediatric patients at least 7 years old with a head circumference of 50 cm or more, who are receiving chemotherapy likely to cause hair loss due to non-malignant conditions like Sickle Cell Disease or solid tumors (excluding brain tumors). It's not for those with past adverse reactions to scalp cooling, certain cold-related diseases, active scalp infections, or high risk of brain/scalp metastasis.

Inclusion Criteria

I am taking medication that has caused complete hair loss.

I am on chemotherapy that may cause hair loss.

I am at least 7 years old.

Exclusion Criteria

I am currently receiving chemotherapy for blood cancer.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cooling cap therapy alongside chemotherapy, with scalp cooling beginning 30-45 minutes prior to chemotherapy and continuing for 120-180 minutes post-infusion.

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of adverse events and hair loss.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Paxman Scalp Cooling System

Trial Overview The study tests the Paxman Scalp Cooling System's ability to prevent hair loss in children undergoing chemotherapy. Participants will use this device and undergo alopecia assessments and complete questionnaires about their experience as part of the research.

How Is the Trial Designed?

Group I: Cooling Cap Therapy Experimental Treatment 3 Interventions

Participants receiving cooling cap therapy

Paxman Scalp Cooling System is already approved in United States, European Union for the following indications:

Approved in United States as Paxman Scalp Cooling System for:

• Prevention of chemotherapy-induced alopecia in patients with solid tumor cancers

Approved in European Union as Paxman Scalp Cooling System for:

• Prevention of chemotherapy-induced alopecia in patients with solid tumor cancers

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Published Research Related to This Trial

In a study involving 94 patients, the Paxman Scalp Cooler was found to be effective in reducing chemotherapy-induced alopecia, with 89% of patients experiencing success in hair retention according to the WHO grading system.

Patient acceptability was high, with 85% of participants reporting comfort during the scalp cooling process, indicating that this method is not only effective but also well-tolerated by patients undergoing chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicentre study to determine the efficacy and patient acceptability of the Paxman Scalp Cooler to prevent hair loss in patients receiving chemotherapy. Massey, CS.[2022]

Scalp cooling has been used since the 1970s as a method to prevent hair loss caused by chemotherapy, which is a common and distressing side effect for cancer patients.

The article discusses the varying opinions and controversies surrounding scalp cooling, highlighting the need for further research and recommendations to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is wrong with the 30-year-old practice of scalp cooling for the prevention of chemotherapy-induced hair loss? Breed, WP.[2008]

In a study of 238 patients undergoing docetaxel chemotherapy, both scalp cooling methods (Paxman PSC-2 machine and cold cap) significantly reduced the risk of chemotherapy-induced alopecia by 78%, with similar effectiveness between the two methods.

Alopecia rates were notably lower in patients using cooling methods, with only 23% experiencing hair loss with Paxman and 27% with cold cap compared to 74% in the no cooling group, particularly effective during 3-weekly docetaxel treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment. Betticher, DC., Delmore, G., Breitenstein, U., et al.[2022]

Implementing a scalp cooling program at a community breast health center significantly helps patients undergoing cancer treatment to limit hair loss, as those who received education and assistance with cold caps retained more hair.

Having a trained cold capper and providing detailed education on the use of cold caps increases the effectiveness of this intervention, making it a valuable support for patients experiencing alopecia during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scalp Cooling: Implementing a Cold Cap Program at a Community Breast Health Center. Heery, M., Cohen, S., Mena, Z.[2020]

In a study of 48 Japanese breast cancer patients undergoing chemotherapy, the use of a scalp-cooling device significantly reduced the incidence of alopecia, with 26.7% of patients experiencing no hair loss compared to 0% in the control group.

The scalp-cooling device also facilitated faster recovery of hair volume after chemotherapy, with 85.7% of patients in the scalp-cooling group seeing a ≥50% increase in hair volume within 12 weeks, compared to 50% in the control group, and no serious adverse events were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Scalp Cooling in Preventing and Recovering From Chemotherapy-Induced Alopecia in Breast Cancer Patients: The HOPE Study. Kinoshita, T., Nakayama, T., Fukuma, E., et al.[2020]

A properly fitted scalp cooling cap was effective in promoting hair regrowth during adjuvant chemotherapy in a 51-year-old Japanese woman with breast cancer, highlighting its potential as a supportive treatment to prevent chemotherapy-induced hair loss.

The case emphasizes the importance of ensuring the scalp cooling cap fits well, especially at the vertex of the head, to maximize its effectiveness, suggesting a need for further development of customized caps for different patient anatomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair regrowth using a properly fitted scalp cooling cap during adjuvant chemotherapy for breast cancer. Fushimi, A., Shinozaki, N., Takeyama, H.[2020]

Scalp cooling (SC) is effective in preventing chemotherapy-induced alopecia, reducing the incidence of hair loss greater than 50% by 43% compared to control groups, based on a systematic review of 13 studies involving 832 participants.

The study found no significant differences in efficacy between automated and non-automated cooling systems, and no serious adverse events related to scalp cooling were reported, indicating it is a safe intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Scalp cooling for the prevention of chemotherapy-induced alopecia: systematic review and meta-analysis.] Trujillo-Martín, MM., de Armas-Castellano, A., González-Hernández, Y., et al.[2023]

Scalp cooling is an effective method to prevent chemotherapy-induced hair loss in patients with solid tumors, and recent studies show it does not increase the risk of scalp metastasis.

Advancements in scalp cooling technology and reduced cooling times may enhance its adoption in clinical practice, alongside ongoing research into the genetic factors related to hair loss during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of scalp cooling for chemotherapy-induced hair loss. Young, A., Arif, A.[2021]

The DigniCap Scalp Cooling System has a 66.3% success rate in preventing chemotherapy-induced hair loss, significantly outperforming a nonrandomized control group with a 0% success rate, based on a study of 106 participants.

Scalp cooling not only helps preserve hair during chemotherapy but also improves the quality of life for patients, making it a valuable addition to standard cancer care, with FDA clearance for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The DigniCap Scalp Cooling System and its use in the treatment of chemotherapy-induced alopecia. Mustoe, MM., Lee, CM., Melisko, ME., et al.[2019]

Recent prospective studies in the U.S. support the efficacy and safety of scalp cooling to prevent chemotherapy-induced hair loss, particularly for patients receiving taxane-based chemotherapy regimens.

While scalp cooling can cause mild side effects like scalp pain and chills, these are generally tolerable, and concerns about scalp metastases are low, suggesting that scalp cooling should be more widely used despite logistical challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of Chemotherapy-Induced Alopecia With Scalp Cooling. Kruse, M., Abraham, J.[2019]

Citations

1. paxmanscalpcooling.com paxmanscalpcooling.com/efficacy-safety/

Efficacy & Safety Hair preservation was oncologist graded at 53 of 95 successful patients in the cooling group and 0 of 47 successful patients in the control group. Read More.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04764357

Study Of Cold Cap Therapy For Prevention of Hairloss in ... 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7563013/

Scalp cooling to prevent chemotherapy-induced alopecia Nangia et al. reported that scalp-cooled patients using Paxman devices under taxane-based regimens are more likely to have higher rates of hair preservation (59 ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1462388903000942

A multicentre study to determine the efficacy and patient ... Use of the Paxman Scalp Cooler was adjudged a success for 89% of all patients using the WHO grading system for alopecia and for 87% of patients being ...

5. paxmanscalpcooling.com paxmanscalpcooling.com/wp-content/uploads/2025/04/0064_Paxman-Drug-Bible_Drug_New-Registry-Data_B5_08-2024-DIGITAL.pdf

Efficacy, Data and Cooling Times Images below illustrate the increased rates of hair regrowth shown in a trial setting, achieving Grade 0 alopecia and full hair density within 12 weeks of the ...

6. paxmanscalpcooling.com paxmanscalpcooling.com/efficacy-safety/us-safety-information/

Paxman Scalp Cooling Safety Information - US Scalp cooling safety information for the US. Includes scalp metastases and survival rate data, intended use, and contraindications.

7. paxmanscalpcooling.ca paxmanscalpcooling.ca/efficacy-safety/

Scalp Cooling Efficacy and Safety | Clinical Data Scalp cooling efficacy for preventing chemotherapy-induced alopecia has been proven in many clinical trials for all solid tumor cancers.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2468294220301155

Safety and efficacy of scalp cooling system in preventing ... Scalp cooling was observed to be more effective in reducing chemotherapy-induced alopecia in patients treated with taxane-based chemotherapy over ...

9. scalpcoolingstudies.com scalpcoolingstudies.com/study-library/

Data Library Archive - Scalp Cooling Study Library - Paxman A multicentre study to determine the efficacy and patient acceptability of the Paxman Scalp Cooler to prevent hair loss in patients receiving chemotherapy.