Trials / Unknown
UnknownNCT03429972
Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Patients With Early and Locally Advanced Breast Cancer
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- Sponsor
- National Cancer Centre, Singapore · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Elasto-Gel™ | Elasto-Gel™ hypothermia mitts and slippers contain glycerine, which has thermal properties, allowing use for cold therapies. |
| DRUG | Paclitaxel | 80mg/m\^2 of Paclitaxel is administered by infusion for 60 mins once a week, for a total of 12 cycles |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2019-09-01
- Completion
- 2020-06-01
- First posted
- 2018-02-12
- Last updated
- 2018-03-14
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT03429972. Inclusion in this directory is not an endorsement.