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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 up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trial is testing if using cold therapy (cryotherapy) can help reduce nerve damage in patients who are receiving chemotherapy with paclitaxel. Paclitaxel often causes nerve problems, and the cold therapy aims to protect the nerves by reducing inflammation and slowing down damage. Cryotherapy has been studied in various trials for its potential to prevent paclitaxel-induced peripheral neuropathy, with mixed results.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
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: 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
72 Previous Clinical Trials
22,290 Total Patients Enrolled
3 Trials studying Breast Cancer
50 Patients Enrolled for Breast Cancer
Mary J Wilkinson, MDPrincipal InvestigatorMedical Oncology & Hematology Associates of Northern Virginia
~4 spots leftby Nov 2025
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