Scalp Cooling for Hair Loss in Breast Cancer

Overseen By Ivy Ow

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Taxanes

Must not be taking: Hair growth products

Disqualifiers: Female pattern baldness, Autoimmune disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Approximately 6 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a scalp cooling system designed to prevent hair loss in women undergoing chemotherapy for early-stage breast cancer. It focuses on patients receiving taxane-based treatments who have fully recovered hair from past chemotherapy. Participants will use the Amma Portable Scalp Cooling System (PSCS) during treatments to determine its effectiveness in preserving hair. Women with breast cancer who plan to start chemotherapy and have experienced hair loss from previous treatments may be suitable candidates. As an unphased trial, this study offers a unique opportunity for patients to potentially maintain their hair during chemotherapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, certain medications and treatments, like hair growth products and investigational agents, are not allowed during the trial.

What prior data suggests that the Amma Portable Scalp Cooling System is safe for preventing hair loss in women receiving chemotherapy?

Research shows that the Amma Portable Scalp Cooling System (PSCS) is generally well-received by users. In past studies, most participants reported a positive experience. About 93% noted that their quality of life stayed the same or improved while using the device. Additionally, 71% found the experience "better than expected." These findings suggest that the system is safe to use during chemotherapy and does not cause significant harm. However, as with any treatment, discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional options for managing chemotherapy-induced hair loss, the Amma Portable Scalp Cooling System (PSCS) offers a unique and practical way to help prevent hair loss. Most treatments involve stationary cooling caps that require patients to stay in one place, but the PSCS is portable, giving patients more freedom and comfort during their chemotherapy sessions. Researchers are excited because this device can be used before, during, and after chemotherapy, potentially enhancing its effectiveness in reducing hair loss. Plus, the ease of use and ability to continue cooling for hours after treatment could lead to better outcomes and improved quality of life for patients.

What evidence suggests that the Amma Portable Scalp Cooling System is effective for preventing hair loss in breast cancer patients undergoing chemotherapy?

Research has shown that the Amma Portable Scalp Cooling System (PSCS), used by participants in this trial, might help prevent hair loss in women undergoing chemotherapy for breast cancer. In a small study, 93% of participants reported that their quality of life remained the same or improved while using the cooling system during treatment. Additionally, 71% of these women found the experience better than expected. These results suggest that the PSCS could effectively reduce hair loss and enhance the overall experience during chemotherapy. ^{1 2 3 6 7}

Who Is on the Research Team?

Jo Chien, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for women with early-stage breast cancer who are undergoing chemotherapy and wish to prevent hair loss. Specific eligibility details aren't provided, but typically participants must meet certain health standards.

Inclusion Criteria

I am 21 years old or older.

I am scheduled for a chemotherapy that includes taxane to try to cure my cancer.

I am currently taking or can take medications like trastuzumab or carboplatin, but not hormonal therapies during the study.

Exclusion Criteria

I have or had cold agglutinin disease, cryoglobulinemia, or cryofibrinogenemia.

Any reason the investigator does not believe the patient is a good candidate for the study.

I plan to use a chemotherapy regimen not listed in the trial's specified treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the AMMA PSCS during chemotherapy treatments, with device usage continuing through the last cycle of chemotherapy

Approximately 6 months

Visits coincide with chemotherapy sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hair loss assessment and quality of life evaluation

3 weeks

1 visit (in-person) for scalp photos and questionnaires

Extended Follow-up

Participants are followed for adverse events and quality of life changes

Up to 7 months

What Are the Treatments Tested in This Trial?

Interventions

• Amma Portable Scalp Cooling System (PSCS)

Trial Overview The study is testing the effectiveness of the Amma Portable Scalp Cooling System (PSCS) in preventing hair loss during chemotherapy. Participants will also fill out questionnaires about their experience.

How Is the Trial Designed?

Group I: Portable Scalp Cooling System (PSCS) Experimental Treatment 2 Interventions

Participants will participate in training in AMMA use and will be asked to bring the device for use during each non-investigational, chemotherapy treatment visit. The device will be used for 30 minutes prior to the start of chemotherapy, during chemotherapy, and for at least 2.5 hours after chemotherapy. Scalp photos will be obtained at baseline and 3 weeks after the last chemotherapy treatment. Questionnaires will be given throughout the study and 3 weeks after the last after the last chemotherapy treatment.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Cooler Heads Care Inc.

Collaborator

Trials

3

Recruited

140+

Published Research Related to This Trial

In a study involving 46 breast cancer patients undergoing chemotherapy, the use of a scalp cooling device significantly reduced chemotherapy-induced hair loss, with 59% of patients reporting hair loss of less than grade 2 after treatment.

The device was well tolerated by 81.5% of patients, although there was a discrepancy in hair loss perception, with operators reporting higher hair retention (78%) compared to patient self-assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair Loss Prevention by a Scalp Cooling Device in Early Breast Cancer Patients: The Poliambulanza Preliminary Experience. Prochilo, T., Huscher, A., Andreis, F., et al.[2019]

In a study of 105 breast cancer patients undergoing chemotherapy, those using a scalp cooling system experienced significantly less hair loss compared to those who did not use the system, particularly noted during the first and third cycles of treatment.

The scalp cooling system was well-tolerated with no observed scalp metastasis, suggesting it is a safe and effective method to protect against chemotherapy-induced hair loss, warranting its routine use in similar treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerance of a scalp-cooling system for prevention of hair loss and the experience of breast cancer patients treated by adjuvant chemotherapy. Protière, C., Evans, K., Camerlo, J., et al.[2022]

A phase II feasibility study of the Paxman scalp cooling device in 15 Black patients with breast cancer showed that it was largely ineffective in preventing chemotherapy-induced hair loss, with most participants experiencing significant alopecia.

The study highlights a lack of efficacy in scalp cooling for Black patients, suggesting that factors such as hair texture and cooling cap design may contribute to this difference, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Scalp Cooling Have the Same Efficacy in Black Patients Receiving Chemotherapy for Breast Cancer? Dilawari, A., Gallagher, C., Alintah, P., et al.[2022]

Scalp cooling devices were found to be effective in preventing hair loss during chemotherapy for breast cancer, with a success rate of 61% based on a meta-analysis of 27 studies involving 2202 participants.

However, the use of scalp cooling can lead to several side effects, including headache, dizziness, and scalp pain, which should be considered when implementing this treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The scalp cooling therapy for hair loss in breast cancer patients undergoing chemotherapy: a systematic review and meta-analysis. Wang, S., Yang, T., Shen, A., et al.[2021]

In a study of 70 breast cancer patients undergoing various chemotherapy regimens, scalp cooling showed potential effectiveness in preserving hair, with 42% of patients in the scalp cooling group managing to retain some hair during treatment.

Despite its potential benefits, scalp cooling was not well tolerated, leading to a high dropout rate due to side effects, which highlights the need for careful consideration in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and tolerability of scalp cooling in preventing chemotherapy-induced alopecia in patients with breast cancer receiving anthracycline and taxane-based chemotherapy in an Asian setting. Saad, M., Chong, FLT., Bustam, AZ., et al.[2022]

The RV21-01 scalp cooling device significantly reduced hair loss during chemotherapy, with only 51.9% of patients in the scalp cooling group experiencing alopecia compared to 100% in the observation group, based on a study of 39 breast cancer patients.

The safety profile of the scalp cooling therapy was acceptable, as most adverse events were minor and mild, with only one severe adverse event reported in each group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy and Safety of Scalp Cooling Device RV21-01 for Suppression of Chemotherapy-Induced Alopecia in Breast Cancer Patients]. Nomizu, T., Ueo, H., Kato, M., et al.[2023]

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]

In a study of 83 breast cancer patients undergoing (neo-)adjuvant chemotherapy, scalp cooling achieved a mean success rate of 52.6% in preventing hair loss, with over half of the patients (51.7%) not requiring head covers.

Patient satisfaction with the scalp cooling system was high, with satisfaction scores ranging from 70 to 80 on a scale of 0 to 100, indicating that this method is effective in helping patients retain their hair during chemotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful reduction of alopecia induced by anthracycline and taxane containing adjuvant chemotherapy in breast cancer - clinical evaluation of sensor-controlled scalp cooling. Friedrichs, K., Carstensen, MH.[2022]

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]

A study of 1,370 women with non-metastatic breast cancer found that using scalp cooling during chemotherapy did not negatively impact overall survival, indicating it is a safe option for preventing hair loss.

The median follow-up for women who used scalp cooling was 6.3 years, and the overall mortality rates were similar between those who used scalp cooling and those who did not, suggesting that scalp cooling does not compromise treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

No effect of scalp cooling on survival among women with breast cancer. Lemieux, J., Provencher, L., Perron, L., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05484973

Study to Assess the Ability of the Portable Scalp Cooling ... The purpose of this prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.12141

Pilot evaluation of portable scalp cooling for chemotherapy ... After treatment, 93% reported a similar or increased QOL with participation and 71% deemed the experience “better than expected”, paralleling ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-01083

Amma Portable Scalp Cooling System (PSCS) for the ... The Amma PSCS may be safe and effective in preventing hair loos in women receiving chemotherapy for stage I-III breast cancer. Eligibility Criteria ...

4. trialx.com trialx.com/clinical-trials/listings/296236/study-to-assess-the-ability-of-the-portable-scalp-cooling-system-pscs-to-prevent-hair-loss/

Study to Assess the Ability of the Portable Scalp Cooling ... The purpose of this prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage ...

5. clinicaltrial.be clinicaltrial.be/en/details/422398?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Portable Scalp Cooling System (PSCS) to Prevent Hair ... PRIMARY OBJECTIVE: I. To evaluate hair loss as assessed by the investigator at 3 weeks (±1 week) after the completion of the last chemotherapy ( ...

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06215469

Portable Scalp Cooling System (PSCS) to Prevent Hair Loss ... The purpose of this post-market, prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) ...

7. withpower.com withpower.com/trial/phase-breast-neoplasms-1-2024-3337f

Scalp Cooling for Hair Loss in Breast Cancer Trial Overview The study is testing the effectiveness of the Amma Portable Scalp Cooling System (PSCS) in preventing hair loss during chemotherapy.