What side effects are associated with this type of intervention?

Common treatments for breast cancer include chemotherapy agents such as sacituzumab govitecan, trastuzumab deruxtecan, and eribulin. These treatments are associated with side effects like alopecia (hair loss), nausea, fatigue, neutropenia (low white blood cell count), and peripheral neuropathy (nerve damage). Scalp cooling systems like the Paxman Scalp Cooling System are used to mitigate hair loss by reducing blood flow to hair follicles during chemotherapy.

What prior FDA approvals exist?

The FDA has approved several chemotherapy agents for the treatment of breast cancer, including doxorubicin, paclitaxel, and cyclophosphamide, which are commonly associated with hair loss. Scalp cooling systems, like the Paxman Scalp Cooling System, are used to reduce blood flow to hair follicles during chemotherapy to minimize hair loss. Other FDA-approved treatments for breast cancer include targeted therapies such as trastuzumab and endocrine therapies like tamoxifen. These treatments, while effective against cancer, often have side effects that can impact patients' quality of life, making supportive measures like scalp cooling important.

What other types of research exist?

Promising alternatives to the Paxman Scalp Cooling System for managing chemotherapy-induced alopecia in breast cancer patients include: <ol> <li>Low-dose oral minoxidil, which has shown improvement in hair density without significant adverse effects.</li> <li></li> </ol> Topical bimatoprost, which has been effective in enhancing eyelash and eyebrow growth in patients with chemotherapy-induced hypotrichosis. 3. Spironolactone, a nontoxic therapy that can be considered for persistent alopecia following cancer therapy. 4. Topical menthol, which has shown rapid symptomatic improvement in painful neuropathy and may have potential benefits for hair regrowth.

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Scalp Cooling for Breast Cancer

Phase 2

Recruiting

Led By Elahe Salehi, DNP, ANP-BC

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

One of the following full dose chemotherapy regimens must be planned for at least 4 cycles: Sacituzumab govitecan (IMMU-132) 10 mg/kg administered intravenously on days 1 and 8 of each 21-day cycle, Trastuzumab deruxtecan 5.4 mg/kg administered intravenously once every 3 weeks, Eribulin 1.4 mg/m2 administered intravenously on days 1 and 8 of each 21-day cycle

Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2

Must not have

Baseline alopecia (defined CTCAE 5.0 grade > 0, see Appendix B)

Known scalp metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from the scalp cooling may include headaches or discomfort due to cold temperatures. The chemotherapies involved may cause typical side effects such as fatigue, nausea, low blood counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have metastatic breast cancer and can care for myself.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am experiencing some level of hair loss.

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My cancer has spread to my scalp.

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I am scheduled for chemotherapy to destroy my bone marrow.

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I am currently taking medication to treat my cancer.

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I have a blood cancer, such as leukemia or lymphoma.

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I have lichen planus or lupus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hair Loss Rate

Secondary study objectives

Change in Patient Reported Quality of Life

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)Experimental Treatment2 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 Treatment2 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 Treatment2 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 Control1 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 Control1 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 SYSTEMActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab govitecan

2017

Completed Phase 3

~530

Eribulin

2012

Completed Phase 3

~2740

Trastuzumab deruxtecan

2021

Completed Phase 2

~730

Paxman Scalp Cooling System

2018

N/A

~130

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer, such as sacituzumab govitecan, trastuzumab deruxtecan, and eribulin, work through different mechanisms to target cancer cells. Sacituzumab govitecan is an antibody-drug conjugate that delivers a chemotherapy agent directly to cancer cells, minimizing damage to healthy cells. Trastuzumab deruxtecan also targets HER2-positive cancer cells with a similar antibody-drug conjugate approach, enhancing specificity and efficacy. Eribulin, a microtubule inhibitor, disrupts cell division, leading to cancer cell death. These treatments are crucial for breast cancer patients as they offer targeted and effective options, potentially improving outcomes and reducing side effects. Scalp cooling during these treatments can help mitigate chemotherapy-induced alopecia by reducing blood flow to hair follicles, thereby preserving hair and improving patients' quality of life.

No effect of scalp cooling on survival among women with breast cancer.Impact of hot flashes on quality of life among postmenopausal women being treated for breast cancer.