drugset / Trial / NCT03429972

Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients

NCT03429972 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

The trial will be preceded by a pilot phase study in 5 patients. This will then be followed by the randomized 1:1 phase II trial testing the utility of regional cryotherapy in preventing or reducing paclitaxel-induced peripheral neuropathy compared to no treatment. It is hypothesized that cryotherapy causes regional blood vessel constriction and decreases the paclitaxel exposure to the distal epithelial nerve fibres, thus resulting in decreased nerve damage.

Timeline

Start
2016-09
Primary completion
2019-09
Completion
2020-06

Drugs

EvaluationDrugModalityDoseRoute
Background Paclitaxel Small molecule 80 mg/m2 Other

Indications