Prevention of Paclitaxel Neuropathy With Cryotherapy

September 30, 2015 updated by: Mary Wilkinson, Medical Oncology & Hematology Associates of Northern Virginia
The purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Medical Oncology & Hematology Associates of Northern Virginia
      • Reston, Virginia, United States, 20190
        • Medical Oncology & Hematology Associates of Northern Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  1. Women 18 years of age or older
  2. Histologically or cytological proven diagnosis of breast cancer Stage I- III.
  3. Must pl an to receive weekly paclitaxel treatment in either the adjuvant or neoadjuvant setting.
  4. May have received prior treatment including, radiation, surgery chemotherapy hormone and biologics.
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  6. Patient signed informed consent.
  7. Patient willing and able to comply with scheduled visits and treatment plan.

Exclusion Criteria

  1. Patient presents with Grade 2 or greater peripheral neuropathy.
  2. History of Raynaud's Disease.
  3. Patient presents open or poorly-healing wounds on the hands or feet.
  4. Patients with cold intolerance.
  5. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryotherapy
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.
Drug: Paclitaxel
Other Names:
  • Taxol
  • Taxanes
Other: Cryotherapy
Other Names:
  • Cold therapy
  • Elasto gel™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.
Time Frame: From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of completion of weekly adjuvant paclitaxel with the use of cryotherapy.
Time Frame: From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Oncology & Hematology Associates of Northern Virginia

Collaborators

Inova Health Care Services

Investigators

  • Principal Investigator: Mary J Wilkinson, MD, Medical Oncology & Hematology Associates of Northern Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Anticipated)

March 1, 2017

Study Registration Dates

First Submitted

August 25, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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