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Scalp Cooling for Breast Cancer

N/A
Waitlist Available
Led By Shari Goldfarb, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chemotherapy must be planned for at least 4 cycles of full-dose anthracycline plus cyclophosphamide followed by taxane based chemotherapy regimen
New diagnosis of breast cancer stage I-IV
Must not have
Subjects who have had >/=1 previous chemotherapy exposure resulting in alopecia
An existing history of scalp metastases or suspected presence of scalp metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 44 weeks from the start of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a special cooling cap can safely and effectively prevent hair loss in breast cancer patients undergoing chemotherapy by lowering scalp temperature. Scalp cooling devices have been used to prevent chemotherapy-induced hair loss, with several studies supporting their effectiveness.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort from the cold temperature on the scalp during treatment sessions. There's also a risk that cooling might not fully prevent hair loss.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for a specific chemotherapy plan including anthracycline, cyclophosphamide, and taxane.
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I have been newly diagnosed with breast cancer at any stage.
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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 have lost hair due to chemotherapy.
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I have or might have cancer that has spread to my scalp.
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I am scheduled for chemotherapy to destroy my bone marrow.
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I do not have any other cancer types besides the one being treated.
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I have noticeable hair loss.
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I have had chemotherapy before.
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I am 75 years old or older.
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I am male.
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I have had, or will have, radiation therapy to my skull.
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I am sensitive to cold or have conditions related to cold sensitivity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 44 weeks from the start of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 44 weeks from the start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety as assessed by CTCAE

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Breast CancerExperimental Treatment1 Intervention
Any adult woman with a new diagnosis of breast cancer, Stage I-III

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 include chemotherapy, hormonal therapy, and targeted therapy. Chemotherapy targets rapidly dividing cells, including cancer cells and hair follicles, leading to hair loss. Hormonal therapies, like tamoxifen, block hormones that promote cancer growth. Targeted therapies, such as HER2 inhibitors, specifically target cancer cell proteins to inhibit their growth. Understanding these mechanisms helps in selecting appropriate treatments and managing side effects, such as hair loss, which can be mitigated by scalp cooling systems that reduce blood flow to hair follicles.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,976 Previous Clinical Trials
599,466 Total Patients Enrolled
207 Trials studying Breast Cancer
82,929 Patients Enrolled for Breast Cancer
Shari Goldfarb, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
1,372 Total Patients Enrolled
7 Trials studying Breast Cancer
1,322 Patients Enrolled for Breast Cancer

Media Library

PAXMAN Scalp Cooler Clinical Trial Eligibility Overview. Trial Name: NCT04180579 — N/A
Breast Cancer Research Study Groups: Participants with Breast Cancer
Breast Cancer Clinical Trial 2023: PAXMAN Scalp Cooler Highlights & Side Effects. Trial Name: NCT04180579 — N/A
PAXMAN Scalp Cooler 2023 Treatment Timeline for Medical Study. Trial Name: NCT04180579 — N/A
~2 spots leftby May 2025