Scalp Cooling for Hair Loss

Recruiting at 1 trial location

Overseen By Chris Schultz, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Cooler Heads Care Inc.

Must be taking: Taxanes

Must not be taking: Hormone therapy

Disqualifiers: Autoimmune disease, Brain radiation, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 months

99 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 cancer. Additionally, the purpose is also to assess the safety, tolerability and compliance, quality of life, and satisfaction with hair preservation after CT treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, hormone therapy concurrent with chemotherapy is not allowed, and certain hair growth products are also excluded.

Is scalp cooling safe for humans?

Scalp cooling is generally considered safe for humans, with most adverse effects being minor, such as scalp pain, headache, and chills. The risk of scalp metastases (cancer spreading to the scalp) is low, and the treatment is deemed acceptable for most patients. ^{1 2 3 4 5}

How does the AMMA Portable Scalp Cooling System treatment differ from other treatments for hair loss?

The AMMA Portable Scalp Cooling System is unique because it offers a portable solution for reducing hair loss by cooling the scalp, which can be more convenient and accessible compared to traditional, stationary scalp cooling devices used during chemotherapy. ^{3 6 7 8 9}

What data supports the effectiveness of the AMMA Portable Scalp Cooling System treatment for hair loss?

Research shows that scalp cooling can effectively reduce hair loss in patients undergoing chemotherapy, with studies indicating that around 63.5% of patients experience good hair preservation. Additionally, scalp cooling has been shown to help with faster hair volume recovery after chemotherapy. ^{6 7 8 10 11}

Who Is on the Research Team?

Kate Dilligan

Principal Investigator

Cooler Heads Inc.

Are You a Good Fit for This Trial?

This trial is for women over 21 with early-stage breast cancer (stage I, II, or III) planning to undergo a taxane-containing chemotherapy regimen. Participants should have recovered from any previous chemo-induced hair loss and be in good health with a Karnofsky performance status of 80% or greater.

Inclusion Criteria

I can be on certain cancer drugs like trastuzumab during the study, but not hormonal therapies.

I will finish my current chemotherapy within six months.

Willing and able to sign informed consent for this study

Exclusion Criteria

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

A serious concurrent infection or medical illness which would jeopardize the ability of the patient to complete the planned therapy and follow-up

Participation in any other clinical investigation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive chemotherapy with the use of the AMMA Portable Scalp Cooling System to prevent hair loss

Up to 6 months

Each chemotherapy treatment visit

Follow-up

Participants are monitored for safety, tolerability, and effectiveness of hair preservation after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AMMA Portable Scalp Cooling System

Trial Overview The study is testing the AMMA Portable Scalp Cooling System's effectiveness at preventing hair loss during chemotherapy for breast cancer. It will also evaluate safety, tolerability, compliance, quality of life, and satisfaction with the system.

How Is the Trial Designed?

Group I: All patients will use AMMA Experimental Treatment 1 Intervention

Device: AMMA Portalbe Scalp Cooling System AMMA is indicated for use in chemotherapy infusion centers, during transit from the infusion center andat home and is intended for use by patients who are undergoing chemotherapy treatment and who want to reduce the likelihood of chemotherapy-induced alopecia.

Who Is Running the Clinical Trial?

Cooler Heads Care Inc.

Lead Sponsor

Trials

3

Recruited

140+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

Citations

1. Switzerland pubmed.ncbi.nlm.nih.gov

EVA-Scalp: Evaluation of Patient Satisfaction with a Scalp Cooling Device to Prevent Chemotherapy-Induced Alopecia in Breast Cancer Patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

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

3. France pubmed.ncbi.nlm.nih.gov

[Effectiveness of scalp cooling in chemotherapy]. [2017]

4. 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]

5. 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]

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. 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]

9. Spain pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Ethical, legal, organizational and social issues related to the use of scalp cooling for the prevention of chemotherapy-induced alopecia: A systematic review. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Scalp cooling by cold air for the prevention of chemotherapy-induced alopecia. [2004]