Scalp Cooling for Breast Cancer

Overseen By Mario Lacoutre, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Anthracyclines, Cyclophosphamide, Taxanes

Disqualifiers: Other malignancy, Baseline alopecia, Male, others

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

Compensation: Varies

Number of Visits: Unknown

34 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Shari Goldfarb, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for a specific chemotherapy plan including anthracycline, cyclophosphamide, and taxane.

I am currently taking trastuzumab at standard doses.

I am not pregnant or have a negative pregnancy test if of childbearing age.

Exclusion Criteria

I have lost hair due to chemotherapy.

I have or might have cancer that has spread to my scalp.

I have been diagnosed with migraines or headaches by a doctor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Chemotherapy

Participants receive chemotherapy treatment with scalp cooling to prevent hair loss

44 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• PAXMAN Scalp Cooler

Trial Overview 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.

Participant Groups

Group I: Participants with Breast Cancer Experimental Treatment 1 Intervention

Any adult woman with a new diagnosis of breast cancer, Stage I-III

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+