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Anti-microtubule agent

Cryotherapy for Breast Cancer

Phase 2
Waitlist Available
Led By Mary J Wilkinson, MD
Research Sponsored by Medical Oncology & Hematology Associates of Northern Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
Awards & highlights

Study Summary

The purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.
Secondary outcome measures
Paclitaxel

Trial Design

1Treatment groups
Experimental Treatment
Group I: CryotherapyExperimental Treatment2 Interventions
Each patient will receive cryotherapy administered during weekly paclitaxel treatments by Elasto gel™ Hypothermia mitts and slippers. Patients will wear the mitts and slippers for 15 minutes prior to treatment start, for 60 minutes during treatment, and for 15 minutes following treatment completion, for a total of 90 minutes.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

Medical Oncology & Hematology Associates of Northern VirginiaLead Sponsor
Inova Health Care ServicesOTHER
69 Previous Clinical Trials
22,220 Total Patients Enrolled
3 Trials studying Breast Cancer
126 Patients Enrolled for Breast Cancer
Mary J Wilkinson, MDPrincipal InvestigatorMedical Oncology & Hematology Associates of Northern Virginia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Prevention of Paclitaxel Neuropathy With Cryotherapy
Mary Wilkinson 2014. "Prevention of Paclitaxel Neuropathy With Cryotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02230319.
All > Acl > Neuropathy
~4 spots leftby Apr 2025
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