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?

This trial tests a new scalp cooling device, the AMMA Portable Scalp Cooling System, to prevent hair loss in women undergoing chemotherapy for early-stage breast cancer. The study will assess the device's safety, comfort, and user satisfaction with hair preservation. Women with stage I, II, or III breast cancer planning to undergo chemotherapy with taxane drugs may qualify for this trial. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance quality of life during cancer 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.

What prior data suggests that the AMMA Portable Scalp Cooling System is safe for preventing hair loss during chemotherapy?

Research has shown that since 2015, the FDA has approved scalp cooling to help prevent hair loss during chemotherapy, confirming its general safety. The AMMA Portable Scalp Cooling System is currently being tested for effectiveness and safety in chemotherapy patients.

Previous studies on similar scalp cooling devices have found that patients usually tolerate them well. Common side effects include mild discomfort from the cold, headaches, and feeling cold, which are typically temporary and not serious. So far, no major safety concerns have emerged with scalp cooling treatments.

Overall, researchers are carefully studying the AMMA system to ensure its safety for those seeking to reduce hair loss during chemotherapy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The AMMA Portable Scalp Cooling System is unique because it offers a convenient and flexible way to help prevent hair loss during chemotherapy. Unlike traditional scalp cooling systems that are often confined to the treatment center, AMMA is portable, allowing patients to use it during transit and at home. This means that patients can maintain consistent cooling, which may improve the effectiveness in reducing chemotherapy-induced alopecia. Researchers are excited about this because it empowers patients with more control and comfort in managing one of the most distressing side effects of cancer treatment.

What evidence suggests that the AMMA Portable Scalp Cooling System is effective for preventing hair loss in women receiving chemotherapy for early-stage breast cancer?

Research has shown that cooling the scalp can help prevent hair loss in people receiving chemotherapy. One study with 83 breast cancer patients found that scalp cooling successfully prevented hair loss in 52.6% of cases. In this trial, all participants will use the AMMA Portable Scalp Cooling System, which can be used both in chemotherapy centers and at home, offering greater convenience. Additionally, a small study found that 93% of participants felt their quality of life remained the same or improved while using the system. Overall, these findings suggest that scalp cooling, including the AMMA system, may effectively reduce hair loss during chemotherapy. ^{1 2 5 6 7}

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

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 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]

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 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 (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]

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]

Citations

1. 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 ...

2. 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10137043/

Prevention and Treatment of Chemotherapy-Induced ... CIA interventions include scalp cooling systems (both non-portable and portable) and topical agents to prevent hair loss, versus topical and oral minoxidil.

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

Amma Portable Scalp Cooling System (PSCS) for the ... This clinical trial tests the safety and effectiveness of the Amma Portable Scalp Cooling System (PSCS) in preventing hair loss during certain chemotherapy ...

5. withpower.com withpower.com/trial/phase-breast-cancer-7-2022-82660

Scalp Cooling for Hair Loss 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, ...

6. 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 ...

7. go.drugbank.com go.drugbank.com/conditions/DBCOND0171375

Chemotherapy Induced Alopecia (DBCOND0171375) Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss, No drug interventions, supportive_care, Not Available, recruiting.