The CONTRoL Trial: Cryotherapy vs. cOmpression Neuropathy TRiaL — CONTRoL  

CIPN - Chemotherapy-Induced Peripheral Neuropathy Clinical Trial

Official title: Randomized Controlled Selection Trial of Cryotherapy vs. Compression Therapy for the Prevention of Taxane-induced Peripheral Neuropathy in Breast Cancer Patients

Status Completed

Clinical Trial 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 (NTX) component of the Functional Assessment of Cancer Therapy (FACT) - Taxane questionnaire, following 12 weeks of neoadjuvant/adjuvant chemotherapy with paclitaxel or docetaxel among breast cancer patients.

Clinical Trial 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 used, the frequency with which it is given, and the cumulative dose. Unfortunately, for some patients, symptoms may persist even after discontinuation of the drug due to irreversible nerve damage. As of now, there are no established agents for CIPN prevention.

This is a randomized, placebo-controlled clinical selection trial of interventions for CIPN in patients treated with docetaxel every 3 weeks or paclitaxel on a weekly schedule. Patients will be randomly assigned to receive either frozen gloves and socks, compression gloves and socks, or "loose" gloves and socks (placebo arm) during chemotherapy infusion to study the best intervention at reducing neuropathic pain. ;

Related Conditions & MeSH terms

• CIPN - Chemotherapy-Induced Peripheral Neuropathy
• Peripheral Nervous System Diseases

• NCT number: NCT03873272
• Study type: Interventional
• Source: Columbia University
• Status: Completed
• Phase: N/A
• Start date: April 25, 2019
• Completion date: February 2, 2023