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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is being conducted to compare rates of hair loss in people with metastatic breast cancer who use the Paxman Scalp Cooling System during their standard of care treatment with either sacituzumab govitecan, trastuzumab deruxtecan, or eribulin, versus those who do not use scalp cooling.
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.Check my eligibility
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.See study design
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 belowSelect...
I am planned to receive one of the specified chemotherapy treatments for at least 4 cycles.
Select...
I have metastatic breast cancer and can care for myself.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hair Loss Rate
Secondary outcome measures
Change in Patient Reported Quality of Life
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
Paxman Scalp Cooling System
2018
N/A
~130
Eribulin
2012
Completed Phase 3
~2700
Sacituzumab govitecan
2017
Completed Phase 3
~530
Trastuzumab deruxtecan
2022
Completed Phase 2
~400
Find a Location
Who is running the clinical trial?
Daiichi SankyoIndustry Sponsor
392 Previous Clinical Trials
411,245 Total Patients Enrolled
26 Trials studying Breast Cancer
17,627 Patients Enrolled for Breast Cancer
Gilead SciencesIndustry Sponsor
1,083 Previous Clinical Trials
843,239 Total Patients Enrolled
17 Trials studying Breast Cancer
6,454 Patients Enrolled for Breast Cancer
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,862 Total Patients Enrolled
17 Trials studying Breast Cancer
2,044 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am experiencing some level of hair loss.I am planned to receive one of the specified chemotherapy treatments for at least 4 cycles.I have metastatic breast cancer and can care for myself.My cancer has spread to my scalp.You have cold agglutinin disease or cold urticaria.I am scheduled for chemotherapy to destroy my bone marrow.You have hair at the start of the study.I am currently taking medication to treat my cancer.You have hair when the study starts.I am 18 years old or older.I have a blood cancer, such as leukemia or lymphoma.I have lichen planus or lupus.I will start using the Paxman Scalp Cooling System with my first treatment.I have been diagnosed with migraines or headaches by a doctor.
Research Study Groups:
This trial has the following groups:- Group 1: TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)
- Group 2: ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)
- Group 3: SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)
- Group 4: SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)
- Group 5: ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)
- Group 6: TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM
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.
Is the recruitment phase of this trial still ongoing?
"Affirmative, the clinicaltrials.gov website indicates that this experiment is currently recruiting participants and has been since October 7th 2021. Also, the most recent update was made on January 18th 2022 and it seeks to recruit 120 individuals from 2 distinct sites."
Answered by AI
Has the Paxman Scalp Cooling System acquired its requisite regulatory approval?
"Given the Phase 2 status, which implies that some safety data is present yet efficacy has not been confirmed, our team gave Paxman Scalp Cooling System a score of 2 on their scale."
Answered by AI
What medical conditions has the Paxman Scalp Cooling System been deployed to address?
"Therapeutic interventions often employ the Paxman Scalp Cooling System. This device is also beneficial for patients receiving pharmacotherapy, individuals with metastatic her2-positive breast cancer who have had two or more prior anti-her2 regimens in the metastatic setting, and those dealing with other types of breast cancer."
Answered by AI
How many individuals are being administered treatment through this experiment?
"Affirmative. According to the information found on clinicaltrials.gov, this medical trial is currently enrolling participants and was first posted on October 7th 2021. It has since been updated for the last time on January 18th of 2022, with a goal of recruiting 120 patients from 2 different locations."
Answered by AI
Are there any existing studies or reports that document the efficacy of the Paxman Scalp Cooling System?
"Currently, 100 clinical trials are in progress to assess the efficacy of Paxman Scalp Cooling System. Of these ongoing studies, 22 have reached Phase 3. Most tests for this treatment take place at centres based out of Phoenix, AZ; however, there exist 5493 locations that are running related trails."
Answered by AI
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