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

Trial Summary

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 data supports the effectiveness of the Amma Portable Scalp Cooling System treatment for hair loss in breast cancer patients?

Research shows that scalp cooling devices can help prevent hair loss in breast cancer patients undergoing chemotherapy. In one study, more patients using a scalp-cooling device had no hair loss compared to those who didn't use it, and they also experienced faster hair regrowth after treatment. ^{1 2 3 4 5}

Is scalp cooling safe for humans?

Scalp cooling is generally considered safe for humans, with most side effects being minor, such as scalp pain, headache, and chills. Serious side effects are rare, and the risk of scalp metastases (cancer spreading to the scalp) is low. ^{1 3 6 7 8}

How does scalp cooling differ from other treatments for hair loss in breast cancer patients?

Scalp cooling is unique because it works by reducing the amount of chemotherapy drugs that reach the hair follicles, which helps prevent hair loss during treatment. Unlike other treatments, it is a non-drug approach that involves wearing a cooling cap during chemotherapy sessions, and it has been shown to be effective in reducing hair loss and aiding faster hair recovery after chemotherapy. ^{1 2 5 9 10}

What is the purpose of this trial?

The purpose of this post-market, prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer.

Research Team

Jo Chien, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Hair Loss Prevention by a Scalp Cooling Device in Early Breast Cancer Patients: The Poliambulanza Preliminary Experience. [2019]

2. 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]

3. Switzerland 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. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

No effect of scalp cooling on survival among women with breast cancer. [2022]

5. India 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. [2022]

6. Japan pubmed.ncbi.nlm.nih.gov

[Efficacy and Safety of Scalp Cooling Device RV21-01 for Suppression of Chemotherapy-Induced Alopecia in Breast Cancer Patients]. [2023]

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

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

8. Germany pubmed.ncbi.nlm.nih.gov

The scalp cooling therapy for hair loss in breast cancer patients undergoing chemotherapy: a systematic review and meta-analysis. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Does Scalp Cooling Have the Same Efficacy in Black Patients Receiving Chemotherapy for Breast Cancer? [2022]

10. Germany 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. [2022]