Back to resultsPrevention of Paclitaxel Neuropathy With Cryotherapy
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cryotherapy
Paclitaxel
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring Cryotherapy, Cold therapy, Peripheral Neuropathy, Paclitaxel, Breast Cancer, Symptom management, Prevention
Eligibility Criteria
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.
Sites / Locations
- Medical Oncology & Hematology Associates of Northern Virginia
- Medical Oncology & Hematology Associates of Northern Virginia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cryotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Incidence of grade 2 peripheral neuropathies induced by weekly paclitaxel.
Secondary Outcome Measures
Rate of completion of weekly adjuvant paclitaxel with the use of cryotherapy.
Full Information
NCT ID
NCT02230319
First Posted
August 25, 2014
Last Updated
September 30, 2015
Sponsor
Medical Oncology & Hematology Associates of Northern Virginia
Collaborators
Inova Health Care Services
1. Study Identification
Unique Protocol Identification Number
NCT02230319
Brief Title
Prevention of Paclitaxel Neuropathy With Cryotherapy
Official Title
Prevention of Paclitaxel Neuropathy With Cryotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Oncology & Hematology Associates of Northern Virginia
Collaborators
Inova Health Care Services
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Cryotherapy, Cold therapy, Peripheral Neuropathy, Paclitaxel, Breast Cancer, Symptom management, Prevention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cryotherapy
Other Intervention Name(s)
Cold therapy, Elasto gel™
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol, Taxanes
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary J Wilkinson, MD
Organizational Affiliation
Medical Oncology & Hematology Associates of Northern Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Oncology & Hematology Associates of Northern Virginia
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Medical Oncology & Hematology Associates of Northern Virginia
City
Reston
State/Province
Virginia
ZIP/Postal Code
20190
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prevention of Paclitaxel Neuropathy With Cryotherapy
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