Ignite Creation Date:
2024-05-06 @ 7:58 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02640053
Status:
COMPLETED
Last Update Posted:
2019-09-30
First Post:
2015-12-09
Brief Title:
Topical Cryotherapy in Reducing Pain in Patients With Chemotherapy Induced Peripheral Neuropathy or Paclitaxel Induced Acute Pain Syndrome
Sponsor:
Academic and Community Cancer Research United
Organization:
Academic and Community Cancer Research United
Study Overview
Official Title:
Pilot Clinical Trial Evaluating the Utility of Topical Cryotherapy to Decrease Chemotherapy-Induced Peripheral Neuropathy CIPN and Paclitaxel-Induced Acute Pain Syndrome P-APS A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized pilot clinical trial studies topical cryotherapy cooling hands and feet with ice bags in reducing pain in patients with chemotherapy induced peripheral neuropathy or paclitaxel induced acute pain syndrome Peripheral neuropathy is a nerve problem that causes pain numbness tingling swelling or muscle weakness in different parts of the body Paclitaxel produces a disabling syndrome of acute aches and pains Topical cryotherapy is being studied to see if it can help relieve pain from peripheral neuropathy or acute pain syndrome caused by chemotherapy
Detailed Description:
PRIMARY OBJECTIVES
I To estimate whether topical cryotherapy can alleviate paclitaxel-induced peripheral neuropathy
II To estimate whether topical cryotherapy can alleviate paclitaxel-induced acute pain syndrome P-APS
III To examine the possible relative toxicities related to topical cryotherapy in this study situation
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients apply bags filled with crushed ice to hands and feet for 15 minutes before for 60 minutes during administration and for 15 minutes after finishing administration of paclitaxel
ARM II Patients receive paclitaxel intravenously IV over 60 minutes on weeks 1-12
In both arms courses repeat once a week for 12 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 30 days for 6 months
I To estimate whether topical cryotherapy can alleviate paclitaxel-induced peripheral neuropathy
II To estimate whether topical cryotherapy can alleviate paclitaxel-induced acute pain syndrome P-APS
III To examine the possible relative toxicities related to topical cryotherapy in this study situation
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients apply bags filled with crushed ice to hands and feet for 15 minutes before for 60 minutes during administration and for 15 minutes after finishing administration of paclitaxel
ARM II Patients receive paclitaxel intravenously IV over 60 minutes on weeks 1-12
In both arms courses repeat once a week for 12 weeks in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 30 days for 6 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2015-02014 | REGISTRY | None | None |
| RU221511I | OTHER | None | None |
| P30CA015083 | NIH | Academic and Community Cancer Research United | httpsreporternihgovquickSearchP30CA015083 |