Scalp Cooling for Breast Cancer

Overseen By Mario Lacoutre, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Anthracyclines, Cyclophosphamide, Taxanes

Disqualifiers: Other malignancy, Baseline alopecia, Male, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using the Paxman Scalp Cooling System at lower temperatures can safely prevent hair loss in breast cancer patients undergoing chemotherapy. The study focuses on women newly diagnosed with stage I to III breast cancer who will receive a specific chemotherapy regimen, including drugs like anthracycline and cyclophosphamide. Participants should not have other cancers or a history of hair loss from previous treatments. The aim is to find a comfortable way to help patients keep their hair during treatment. As an unphased trial, this study offers patients the opportunity to contribute to innovative research that could enhance quality of life during chemotherapy.

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 is best to discuss this with the trial team or your doctor.

What prior data suggests that the Paxman Scalp Cooling System is safe for breast cancer patients?

Research has shown that the Paxman Scalp Cooling System is generally safe for breast cancer patients receiving chemotherapy. Studies have found that this system helps reduce hair loss during treatment. Many clinical trials for cancers with solid tumors have confirmed its safety and effectiveness. The system is also approved for use in patients undergoing chemotherapy that often leads to hair loss. Overall, the Paxman Scalp Cooler is well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about scalp cooling for breast cancer patients because it offers a non-invasive way to potentially prevent hair loss during chemotherapy. Unlike standard chemotherapy treatments, which often result in hair loss, the PAXMAN Scalp Cooler works by reducing the temperature of the scalp, which may help minimize the damage to hair follicles during treatment. This approach not only aims to preserve hair but also improves the quality of life and self-esteem for patients undergoing cancer treatment.

What evidence suggests that the Paxman Scalp Cooling System is effective for preventing hair loss in breast cancer patients?

Research has shown that the Paxman Scalp Cooling System can help reduce hair loss in breast cancer patients undergoing chemotherapy. In one study, 56% of patients using the cooling system did not need a head covering by their final treatment. Another study found that 53% of patients experienced only minimal hair loss. Overall, the system appears to help 50% to 80% of patients retain their hair. Scalp cooling is generally well tolerated, with most patients experiencing few side effects. This trial will evaluate the effectiveness of the Paxman Scalp Cooler in managing chemotherapy-related hair loss in participants with breast cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Shari Goldfarb, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older with a new diagnosis of stage I-IV breast cancer, planning to undergo at least 4 cycles of specific chemotherapy. They must not have had prior chemo, no history of significant headaches, other cancers, baseline alopecia, or cold-related conditions. Men and those over 75 are excluded.

Inclusion Criteria

I am scheduled for a specific chemotherapy plan including anthracycline, cyclophosphamide, and taxane.

I am currently taking trastuzumab at standard doses.

I am not pregnant or have a negative pregnancy test if of childbearing age.

Exclusion Criteria

I have lost hair due to chemotherapy.

I have or might have cancer that has spread to my scalp.

I have been diagnosed with migraines or headaches by a doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive chemotherapy treatment with scalp cooling to prevent hair loss

44 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PAXMAN Scalp Cooler

Trial Overview The study tests if the Paxman Scalp Cooling System can safely prevent hair loss when used at lower temperatures than usual in patients receiving certain chemotherapy regimens for breast cancer.

How Is the Trial Designed?

Group I: Participants with Breast Cancer Experimental Treatment 1 Intervention

Any adult woman with a new diagnosis of breast cancer, Stage I-III

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Citations

1. paxmanscalpcooling.com paxmanscalpcooling.com/efficacy-safety/

Efficacy & Safety 56% of patients did not require a head covering during their final chemotherapy treatment. 53% of patients were reported to have minimal hair loss, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10986862/

The Efficacy of Paxman Scalp Cooling System ... Scalp cooling with PSCS significantly reduced the incidence of CIA and was well tolerated in breast cancer patients. The cohort who had received ...

3. paxmanscalpcooling.com paxmanscalpcooling.com/wp-content/uploads/2025/04/0064_Paxman-Drug-Bible_Drug_New-Registry-Data_B5_08-2024-DIGITAL.pdf

Efficacy, Data and Cooling Times Across all drug regimens, there is an average 56% chance of a patient retaining. 50% of their hair when scalp cooling. • Outcomes vary based on drug regimen. – ...

4. theoncologist.onlinelibrary.wiley.com theoncologist.onlinelibrary.wiley.com/doi/10.1002/onco.13690

Does Scalp Cooling Have the Same Efficacy in Black Patients ... Studies report 50%–80% success rates and high patient satisfaction, yet there have been no studies of SC in Black patients. We conducted a phase ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.1095

Assessing the impact of scalp cooling in patients receiving ... The study aimed to enroll 20 pts per arm to provide at least 80% power to detect a 28% decrease in hair loss rate between the SC vs non-SC arms ...

6. paxmanscalpcooling.com paxmanscalpcooling.com/efficacy-safety/us-safety-information/

Paxman Scalp Cooling Safety Information - US Scalp cooling to prevent alopecia after chemotherapy can be considered safe in patients with breast cancer.

7. paxmanscalpcooling.ca paxmanscalpcooling.ca/efficacy-safety/

Scalp Cooling Efficacy and Safety | Clinical Data Hair preservation was oncologist graded at 53 of 95 successful patients in the cooling group and 0 of 47 successful patients in the control group. Read More.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/k173032.pdf

June 7, 2018 Paxman Coolers Limited Heather Crawford ... To assess the efficacy of scalp cooling to reduce alopecia for women undergoing treatment for breast cancer using the. Paxman Scalp Cooler.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11270178/

Expanding the Availability of Scalp Cooling to All Patients ... The Paxman scalp cooling system is approved for use on patients receiving chemotherapy that is likely to cause alopecia, especially taxanes and ...