Prevention of Paclitaxel Neuropathy With Cryotherapy
1 other identifier
interventional
39
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Oct 2014
Shorter than P25 for phase_2 breast-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2014
CompletedFirst Posted
Study publicly available on registry
September 3, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedOctober 1, 2015
September 1, 2015
11 months
August 25, 2014
September 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.
From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
Secondary Outcomes (1)
Rate of completion of weekly adjuvant paclitaxel with the use of cryotherapy.
From the date of randomization until date of first documented incidence of grade 2 peripheral neuropathy, assessed up to 2 years.
Study Arms (1)
Cryotherapy
EXPERIMENTALEach 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Medical Oncology & Hematology Associates of Northern Virginia
Fairfax, Virginia, 22031, United States
Medical Oncology & Hematology Associates of Northern Virginia
Reston, Virginia, 20190, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary J Wilkinson, MD
Medical Oncology & Hematology Associates of Northern Virginia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
August 25, 2014
First Posted
September 3, 2014
Study Start
October 1, 2014
Primary Completion
September 1, 2015
Study Completion
March 1, 2017
Last Updated
October 1, 2015
Record last verified: 2015-09