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

Trial Summary

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 data supports the effectiveness of the treatment Paxman Scalp Cooling System for preventing chemotherapy-induced hair loss in children?

Research shows that the Paxman Scalp Cooling System is effective in preventing hair loss in patients undergoing chemotherapy, with 89% of patients experiencing success in reducing hair loss. Additionally, a study found that scalp cooling helped more patients maintain their hair and recover hair volume faster after chemotherapy compared to those who did not use the treatment. ^{1 2 3 4 5}

Is cold cap therapy safe for preventing hair loss during chemotherapy in children?

Scalp cooling, including the Paxman Scalp Cooling System, is generally considered safe for preventing hair loss during chemotherapy, with minimal side effects like scalp pain, headache, and chills. Studies show it is effective and well-tolerated, with a low risk of serious side effects such as scalp metastases. ^{1 5 6 7 8}

How does the Paxman Scalp Cooling System treatment differ from other treatments for chemotherapy-induced hair loss in children?

The Paxman Scalp Cooling System is unique because it uses a cooling cap to reduce scalp temperature, which helps prevent hair loss during chemotherapy by reducing blood flow to hair follicles. This method is non-invasive and focuses on comfort, with a high success rate in maintaining hair and minimal side effects compared to other treatments. ^{1 2 5 9 10}

What is the purpose of this trial?

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.

Research Team

Deena Levine, MD

Principal Investigator

St. Jude Children's Research Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Scotland 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. [2022]

2. Singapore pubmed.ncbi.nlm.nih.gov

Hair regrowth using a properly fitted scalp cooling cap during adjuvant chemotherapy for breast cancer. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Scalp Cooling in Preventing and Recovering From Chemotherapy-Induced Alopecia in Breast Cancer Patients: The HOPE Study. [2020]

4. England pubmed.ncbi.nlm.nih.gov

The use of scalp cooling for chemotherapy-induced hair loss. [2021]

5. Spain pubmed.ncbi.nlm.nih.gov

[Scalp cooling for the prevention of chemotherapy-induced alopecia: systematic review and meta-analysis.] [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of two scalp cooling systems for the prevention of alopecia associated with docetaxel treatment. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The DigniCap Scalp Cooling System and its use in the treatment of chemotherapy-induced alopecia. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Management of Chemotherapy-Induced Alopecia With Scalp Cooling. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Scalp Cooling: Implementing a Cold Cap Program at a Community Breast Health Center. [2020]

10. Germany 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? [2008]