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A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy

NCT05095051 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2021-11-12

No results posted yet for this study

Summary

The study aims to investigate the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy via a newly developed limb cryocompression device in healthy subjects and cancer patients. The limb cryocompression device will be tested for its safety in delivering limb cryocompression and efficacy in improving the preservation of peripheral nerves during chemotherapy.

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Interventions

DEVICE

Paxman Cryocompression System (PCCS)

Establishing optimal temperature and pressure for limb cryocompression therapy. Healthy subjects will undergo 3 hours of limb cryocompression. The cryocompression device used in this study consists of a control unit, and limb wraps. The control unit contains the coolant reservoir and pump to circulate the coolant and air for compression. It is able to thermoregulate (control the temperature of the circulating coolant) and offer cyclic air pressure in the wraps. The wraps cover the limbs from the elbow/knee to the fingers/toes.

DEVICE

Paxman Cryocompression System (PCCS)

The study population will comprise of cancer patients scheduled to receive weekly paclitaxel chemotherapy for a maximum of 12 cycles. Paclitaxel will be administered as a one-hour infusion. Limb cryocompression sessions comprised of a pre-cooling period (up to one hour), continued with paclitaxel infusion and a post-cooling period (on average 30 minutes after the end of paclitaxel infusion). Overall, limb cryocompression will be administered for no longer than four hours.

Sponsors & Collaborators

  • Paxman Coolers Ltd.

    collaborator UNKNOWN

  • The N.1 Institute for Health, National University of Singapore

    collaborator UNKNOWN

  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Raghav Sundar · National University Hospital, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Singapore

Study Locations

More Related Trials

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 NCT05095051 on ClinicalTrials.gov