Status:
COMPLETED
The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL
Lead Sponsor:
Columbia University
Conditions:
CIPN - Chemotherapy-Induced Peripheral Neuropathy
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
The primary objective of this study is to select the best intervention from cold therapy, compression therapy and placebo at reducing neuropathic pain as measured by the change in the Neurotoxicity (N...
Detailed Description
Chemotherapy-induced peripheral neuropathy (CIPN) is a frequent side effect resulting from the administration of cytotoxic chemotherapeutic agents. The incidence of CIPN can vary on the type of agent ...
Eligibility Criteria
Inclusion
- Age greater or equal to 18 years.
- History of stage I-III breast cancer
- Patient scheduled to be receiving adjuvant or neoadjuvant paclitaxel or docetaxel for at least 12 weeks
- Signed informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%,)
Exclusion
- Prior treatment with taxane or platinum based chemotherapy
- Known history of neuropathy
- Raynaud's phenomenon
- Peripheral arterial ischemia
- Cold intolerance
- Current use of duloxetine which may mitigate chemotherapy-induced peripheral neuropathy (CIPN)
Key Trial Info
Start Date :
April 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2023
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03873272
Start Date
April 25 2019
End Date
February 2 2023
Last Update
October 3 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Columbia University Irving Medical Center
New York, New York, United States, 10032