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
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
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