MedTrace Logo

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

NCT03429972 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2018-03-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Terry Fox Foundation

    collaborator OTHER

  • Duke-NUS Academic Medicine Research Institute

    collaborator UNKNOWN

  • Singapore General Hospital

    collaborator OTHER

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Dr Kiley Loh Wei-Jen, MD · National Cancer Centre, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-09-30
Completion
2020-06-30

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03429972 on ClinicalTrials.gov