Status:
UNKNOWN
Prevention of Paclitaxel Neuropathy With Cryotherapy
Lead Sponsor:
Medical Oncology & Hematology Associates of Northern Virginia
Collaborating Sponsors:
Inova Health Care Services
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if cryotherapy can effectively decrease the rate of neuropathy in patients undergoing weekly paclitaxel treatments.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Women 18 years of age or older
- Histologically or cytological proven diagnosis of breast cancer Stage I- III.
- Must pl an to receive weekly paclitaxel treatment in either the adjuvant or neoadjuvant setting.
- May have received prior treatment including, radiation, surgery chemotherapy hormone and biologics.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Patient signed informed consent.
- Patient willing and able to comply with scheduled visits and treatment plan.
- Exclusion Criteria
- Patient presents with Grade 2 or greater peripheral neuropathy.
- History of Raynaud's Disease.
- Patient presents open or poorly-healing wounds on the hands or feet.
- Patients with cold intolerance.
- Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment contraindicate patient participation.
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2017
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT02230319
Start Date
October 1 2014
End Date
March 1 2017
Last Update
October 1 2015
Active Locations (2)
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1
Medical Oncology & Hematology Associates of Northern Virginia
Fairfax, Virginia, United States, 22031
2
Medical Oncology & Hematology Associates of Northern Virginia
Reston, Virginia, United States, 20190