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

NCT05606068 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-23

No results posted yet for this study

Summary

The study conducted on cancer patients is designed to test safety and efficacy of limb hypothermia in cancer patients using the new Paxman Limb Cryocompression System (PLCS). Ultimately this will lead to the development of a therapy regime that will help to prevent chemotherapy-induced neuropathy in cancer patients.

Conditions

  • Chemotherapy-induced Peripheral Neuropathy

Interventions

DEVICE

Paxman Limb Cryocompression System (PLCS)

The study population will comprise of cancer patients scheduled to receive weekly paclitaxel chemotherapy for a maximum of 12 cycles. Cryocompression will be applied during every cycle of chemotherapy for a duration of up to 4 hours. All chemotherapy patients will receive 30 minutes pre-infusion cooling and 30 minutes post-infusion cooling. Cryocompression for each cycle will not exceed 4 hours. Chemotherapy and concomitant limb cryocompression are performed for 12 cycles and may be continued further in consultation with the PI. 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
  • Curie Oncology, Mount Elizabeth Novena Specialist Centre

    collaborator UNKNOWN
  • National University Hospital, Singapore

    lead OTHER

Principal Investigators

  • Si Jing, Joline Lim · National University Hospital, Singapore

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2026-11-30
Completion
2026-11-30

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 NCT05606068 on ClinicalTrials.gov