Scalp Cooling for Breast Cancer

Recruiting at1 trial location

Overseen by Elahe Salehi, DNP, ANP-BC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

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

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if the Paxman Scalp Cooling System can prevent hair loss in people with advanced breast cancer who are receiving specific treatments. The cooling system works by lowering the scalp temperature to protect hair from the effects of these treatments. The Paxman Scalp Cooling System has been studied in multiple trials and shown to be effective in reducing treatment-induced hair loss in breast cancer patients.

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.

How does scalp cooling differ from other treatments for breast cancer?

Scalp cooling is a unique treatment for breast cancer patients that helps prevent hair loss during chemotherapy by reducing the temperature of the scalp, which decreases blood flow to hair follicles and minimizes the impact of chemotherapy drugs on them. This approach is different from other treatments that focus on directly targeting cancer cells or managing surgical outcomes. ^{1 2 3 4 5}

Research Team

Elahe Salehi, DNP, ANP-BC

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Paxman Scalp Cooling System (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

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

Findings from Research

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 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]

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 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]

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

The effect of plasmakinetic cautery on wound healing and complications in mastectomy. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

A comparison between electrocautery and scalpel plus scissor in breast conserving surgery. [2006]

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

Thermal evaluation of breast disease using local cooling. [2015]

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

Scalpel versus electrocautery in modified radical mastectomy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Radical breast surgery with a contact Nd:YAG laser scalpel. [2007]