drugset / Trial / NCT03429972
Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Phase 2
Unknown
51 enrolled
National Cancer Centre, Singapore
Duke-NUS Academic Medicine Research Institute · collabSingapore General Hospital · collabTerry Fox Foundation · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Paclitaxel | Small molecule | 80 mg/m2 | Other |