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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 44 weeks from the start of treatment
Awards & highlights
Study Summary
This trial is testing if a lower temperature when using the Paxman Scalp Cooling System is safe and tolerable to prevent hair loss in breast cancer patients during chemotherapy.
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.Check my eligibility
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.See study design
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 belowSelect...
I am scheduled for a specific chemotherapy plan including anthracycline, cyclophosphamide, and taxane.
Select...
I have been newly diagnosed with breast cancer at any stage.
Select...
I am 18 years old or older.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety as assessed by CTCAE
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
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Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,934 Previous Clinical Trials
588,776 Total Patients Enrolled
202 Trials studying Breast Cancer
81,103 Patients Enrolled for Breast Cancer
Shari Goldfarb, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
1,434 Total Patients Enrolled
7 Trials studying Breast Cancer
1,384 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have lost hair due to chemotherapy.I have or might have cancer that has spread to my scalp.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.I am currently taking pertuzumab at standard doses.I have been diagnosed with migraines or headaches by a doctor.I am scheduled for chemotherapy to destroy my bone marrow.I am planning to have chemotherapy to try to cure my cancer.I do not have any other cancer types besides the one being treated.I have noticeable hair loss.I have had chemotherapy before.I am 75 years old or older.I have been newly diagnosed with breast cancer at any stage.I am male.I am 18 years old or older.I can receive chemotherapy more frequently if needed.I have had, or will have, radiation therapy to my skull.I am sensitive to cold or have conditions related to cold sensitivity.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with Breast Cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation welcome elderly participants?
"In order to be eligible for this medical trial, the patient's age must fall between 18 and 75 years of age."
Answered by AI
Is the recruitment process for this study still open?
"According to records on clinicaltrials.gov, this particular medical trial is not currently seeking patients; the project was first published in late November 2019 and last updated towards the end of 2022. Even though they are not searching for participants now, there remain 2,601 other trials actively recruiting individuals."
Answered by AI
What criteria must a person satisfy to qualify for participation in this investigation?
"This clinical trial is allowing 34 patients with breast cancer to participate, providing they are aged 18 years or over and 75 years old at most. Notably, all female participants of childbearing age must provide a negative pregnancy test 7 days prior to the study commencing or as per usual medical practice. Women who have taken measures for fertility preservation or ovarian stimulation do not need this test; however their eligibility will be assessed on an individual basis by the investigator."
Answered by AI
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