What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly chemotherapy agents like taxanes and anthracyclines, can cause side effects such as hair loss, nausea, vomiting, fatigue, low white blood cell count, nerve damage, and inflammation of the mucous membranes. Scalp cooling, used to prevent hair loss, can also cause headaches, scalp pain, and cold discomfort.

What prior FDA approvals exist?

The FDA has approved various treatments for breast cancer, including chemotherapy, hormonal therapy, and targeted therapy. One notable FDA-cleared method to minimize chemotherapy-induced hair loss is the use of automated scalp cooling systems, such as the Paxman Scalp Cooling System. These systems work by circulating coolant through a cap to reduce scalp temperature, thereby decreasing blood flow to hair follicles and reducing the uptake of chemotherapy drugs. This method aims to prevent or lessen the severity of hair loss, a common side effect of chemotherapy.

What other types of research exist?

Promising alternatives to the Paxman Scalp Cooling System for minimizing chemotherapy-induced hair loss in breast cancer patients include: 1) Low-dose oral minoxidil, which has shown a 21% improvement in hair density without significant adverse effects. 2) Topical bimatoprost, which has demonstrated benefits for 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. These options provide different mechanisms of action and can be discussed with a healthcare provider for personalized treatment planning.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 44 weeks from the start of treatment

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

0 / 13Eligibility 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 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.