Scalp Cooling for Breast Cancer

Recruiting at 1 trial location

Overseen By Elahe Salehi, DNP, ANP-BC

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must be taking: Sacituzumab, Trastuzumab, Eribulin

Must not be taking: Anti-cancer agents

Disqualifiers: Hematological malignancies, Scalp metastases, Alopecia, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 2 years

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether the Paxman Scalp Cooling System can reduce hair loss in individuals with metastatic breast cancer undergoing specific chemotherapy treatments. It compares those using the cooling system with those who do not while receiving treatments like sacituzumab govitecan, trastuzumab deruxtecan, or eribulin. Suitable candidates have metastatic invasive breast cancer, have hair at the start, and plan to undergo at least four cycles of these chemotherapy treatments. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving any additional anti-cancer agents.

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

Earlier studies have shown that the Paxman Scalp Cooling System is safe for people undergoing chemotherapy. Research indicates that it effectively reduces the risk of hair loss without causing serious side effects. A retrospective study found no link between scalp cooling and negative effects on survival rates for breast cancer patients, suggesting the system is generally well-tolerated. Additionally, the Paxman Scalp Cooling System is approved for reducing chemotherapy-induced hair loss in women with breast cancer, further supporting its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the Paxman Scalp Cooling System because it offers a unique way to potentially reduce hair loss during chemotherapy for breast cancer. Unlike typical treatments that focus solely on combating cancer cells, this system targets hair follicle preservation by cooling the scalp, which may help protect hair from the damaging effects of chemo drugs. This non-invasive method could make a significant difference in quality of life for patients by helping them retain more of their hair during treatment.

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

Research shows that cooling the scalp can help reduce hair loss from chemotherapy. In this trial, some participants will use the Paxman Scalp Cooling System alongside their chemotherapy treatment. Studies have found that the Paxman Scalp Cooling System lowers the risk of hair loss in breast cancer patients. In many studies, about 56% of patients retained at least half of their hair when using this system. Results can vary based on the type of cancer treatment, but overall, the system has proven effective for many people. Most patients tolerate this cooling method well, making it a good option to manage hair loss caused by chemotherapy. ^{2 3 6 7 8}

Who Is on the Research Team?

Elahe Salehi, DNP, ANP-BC

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults with metastatic breast cancer who have hair and are starting one of three specific chemotherapy treatments. They must be in good enough health to participate, not have other cancers or scalp metastases, no baseline alopecia, and can't have certain conditions like cold agglutinin disease.

Inclusion Criteria

I am planned to receive one of the specified chemotherapy treatments for at least 4 cycles.

I have metastatic breast cancer and can care for myself.

You have hair at the start of the study.

Exclusion Criteria

I am experiencing some level of hair loss.

My cancer has spread to my scalp.

You have cold agglutinin disease or cold urticaria.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard of care chemotherapy treatment with or without the Paxman Scalp Cooling System. Treatment cycles are 21 days, repeated up to 2 years based on provider discretion.

Up to 2 years

Visits on days 1, 8, and 21 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment, including hair loss assessments and quality of life evaluations.

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Paxman Scalp Cooling System

Trial Overview The study tests the Paxman Scalp Cooling System's effectiveness at preventing hair loss during chemotherapy (sacituzumab govitecan, trastuzumab deruxtecan, or eribulin) in metastatic breast cancer patients. Participants will either use the cooling system or not as a comparison.

How Is the Trial Designed?

Group I: TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS) Experimental Treatment 2 Interventions

Participants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with TRASTUZUMAB DERUXTECAN. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.

Group II: SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS) Experimental Treatment 2 Interventions

Participants will use Paxman Scalp Cooling System (PSCS) on days 1 and 21 of each of their standard of care (SOC) treatment cycles with SACITUZUMAB GOVITECAN. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.

Group III: ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS) Experimental Treatment 2 Interventions

Participants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with Eribulin. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.

Group IV: ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS) Active Control 1 Intervention

Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with Eribulin. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.

Group V: SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS) Active Control 1 Intervention

Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with SACITUZUMAB GOVITECAN. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.

Group VI: TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM Active Control 1 Intervention

Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with TRASTUZUMAB DERUXTECAN. Study cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Gilead Sciences

Industry Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Eisai Inc.

Industry Sponsor

Trials

524

Recruited

161,000+

Founded

Eisai Inc. was established in 1995 as the U.S. subsidiary of Eisai Co., Ltd.

Headquarters

Woodcliff Lake, NJ, USA

Known For

Neurology and Oncology

Top Products

Aricept (donepezil), Lenvima (lenvatinib), Leqembi (lecanemab), Halaven (eribulin)

Lynn Kramer

Eisai Inc.

Chief Medical Officer since 2019

MD

Tatsuyuki Yasuno

Eisai Inc.

Chief Executive Officer since 2023

MBA from Kellogg School of Management, Northwestern University; Bachelor of Political Science from Waseda University

Daiichi Sankyo, Inc.

Industry Sponsor

Trials

390

Recruited

442,000+

Yuki Abe

Daiichi Sankyo, Inc.

Chief Medical Officer since 2022

MD

Hiroyuki Okuzawa

Daiichi Sankyo, Inc.

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Paxman Coolers Limited

Collaborator

Trials

1

Recruited

120+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Published Research Related to This Trial

The Nd:YAG laser scalpel effectively reduced blood loss during radical and modified radical mastectomy, with an average blood loss of 132 ml in the modified radical mastectomy group, indicating its efficacy as a haemostatic tool.

However, the use of the laser scalpel did not decrease the incidence of axillary seroma, which occurred in 53% of patients, suggesting that it does not offer significant advantages over traditional surgical methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radical breast surgery with a contact Nd:YAG laser scalpel. Wyman, A., Rogers, K.[2007]

The local cooling system effectively differentiated between malignant and benign breast masses, with skin temperature measurements showing an average increase of 1.2°C over cancers and a decrease of 0.6°C over benign masses during a 10-minute cooling process.

The method demonstrated a high diagnostic accuracy, correctly identifying 74% of malignancies and 88% of benign growths, although it had a limitation in misclassifying 45% of cases with asymmetrical diffuse non-malignant disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal evaluation of breast disease using local cooling. Cary, J., Kalisher, L., Sadowsky, N., et al.[2015]

In a study of 46 breast cancer patients undergoing modified radical mastectomy, plasmakinetic cautery significantly reduced the mean drainage duration (5.5 days) and volume (707 mL) compared to electrocautery (7.9 days and 1,093 mL, respectively).

Plasmakinetic cautery demonstrated similar safety profiles to electrocautery, with no significant differences in operation duration, blood loss, or complications like seroma and infection, indicating its efficacy in promoting better wound healing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of plasmakinetic cautery on wound healing and complications in mastectomy. Dogan, L., Gulcelik, MA., Yuksel, M., et al.[2022]

In a study of 49 mastectomy patients, those who had skin flaps created with electrocautery experienced significantly less blood loss during surgery (352 mL) compared to those who used a cold scalpel (507 mL), indicating better hemostasis with electrocautery.

No patients in the electrocautery group required blood transfusions, while three patients in the scalpel group did, suggesting that electrocautery may enhance safety by reducing the need for transfusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scalpel versus electrocautery in modified radical mastectomy. Miller, E., Paull, DE., Morrissey, K., et al.[2022]

In a study of 106 patients with stage I and II breast cancer, using a scalpel plus scissor technique for breast conserving therapy resulted in less histological tissue damage compared to electrocautery, which caused extensive damage.

At the 3-year follow-up, patients who underwent the scalpel plus scissor method had significantly better cosmetic outcomes than those treated with electrocautery, despite similar initial cosmetic results immediately after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison between electrocautery and scalpel plus scissor in breast conserving surgery. Yamamoto, D., Yamada, M., Okugawa, H., et al.[2006]

Citations

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

Efficacy & Safety Scalp cooling efficacy for preventing chemotherapy-induced alopecia has been proven in many clinical trials for all solid tumor cancers.

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. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.12108

Efficacy of paxman scalp cooling system at lower ... 43% of patients had hair preservation at the completion of the study. At 24 weeks post treatment, the average hair count and width was higher ...

5. 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.

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

Paxman Scalp Cooling Safety Information - US Scalp cooling safety information for the US. Includes scalp metastases and survival rate data, intended use, and contraindications.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/K163484.pdf

April 17, 2017 Paxman Coolers Limited Ə Richard Vincins ... The Paxman Scalp Cooler is indicated to reduce the likelihood of chemotherapy-induced alopecia (CIA) in women with breast cancer. Type of Use ( ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2468294220301155

Safety and efficacy of scalp cooling system in preventing ... A recent retrospective cohort study demonstrated no association of scalp cooling with survival in patients with early-stage breast cancer receiving adjuvant or ...