Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-27 @ 11:22 PM
Study NCT ID:
NCT04558034
Status:
TERMINATED
Last Update Posted:
2021-03-08
First Post:
2020-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer
Sponsor:
Parkview Health
Organization:
Study Overview
Official Title:
The Use of Cryotherapy to Prevent Paclitaxel-induced Peripheral Neuropathy and Nail Changes in Women With Breast Cancer
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator retired before study completed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the efficacy of cryotherapy to prevent paclitaxel-induced peripheral neuropathy and nail changes in women with breast cancer.
Detailed Description:
Women with breast cancer receiving paclitaxel will complete the Brief Pain Inventory(BPI), Neuropathic Pain Syndrome Inventory (NPSI)while a member of the research team will conduct an assessment of their nails. Once complete, cryotherapy will be administered 15 minutes prior to the paclitaxel infusion, continuously during and then 15 minutes after completion of the paclitaxel for a total of 90 minutes. Cyrotherapy will be delivered using Elasto-gel mitts and Rapid relief slippers. These items will be changed 45min after initiation to ensure coldness.
There will be two arms of the study. One arm will include subjects who will wear one slipper/one mitt on their foot/hand while the other foot/hand will serve as a control. The other arm will include subjects who will have cryotherapy to both hands and feet. . This process will be repeated for a total of 12 times in conjunction with 12 doses of paclitaxel. At time point 13, during a routine visit to their oncologist, the subjects nails will be reassessed along with completion of the BPI and NPSIA total of 25 subjects will be enrolled in each arm.
There will be two arms of the study. One arm will include subjects who will wear one slipper/one mitt on their foot/hand while the other foot/hand will serve as a control. The other arm will include subjects who will have cryotherapy to both hands and feet. . This process will be repeated for a total of 12 times in conjunction with 12 doses of paclitaxel. At time point 13, during a routine visit to their oncologist, the subjects nails will be reassessed along with completion of the BPI and NPSIA total of 25 subjects will be enrolled in each arm.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: