Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments cryotherapy, paclitaxel
Phase phase 2
Sponsor Medical Oncology & Hematology Associates of Northern Virginia
Collaborator Inova Health System
Start date October 2014
End date September 2015
Trial size 39 participants
Trial identifier NCT02230319, 2014.1

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
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.
cryotherapy Cold therapy
paclitaxel Taxol

Primary Outcomes

Measure
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.

Secondary Outcomes

Measure
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.

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Prevention of Paclitaxel Neuropathy With Cryotherapy
Principal investigator Mary J Wilkinson, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Medical Oncology & Hematology Associates of Northern Virginia.