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

Trial number:
Trial phase:
Study type:
Chemotherapy, Supportive interventions
Overall status:
Not yet recruiting

Study start date

November, 2022

Scientific title

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


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.

Age 21- 80 years.Signed informed consent from patient or legal representative Scheduled to receive weekly paclitaxel chemotherapy Patients may receive other chemotherapy drugs alongside taxane e.g. Platinum/Herceptin.

Open skin wound or ulcers of the limbsHistory of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes Pregnant woman A score of more than 5 in Total Neuropathy Score (TNS) at baseline for cancer patients

Study design

Primary purpose: Prevention, Allocation: N/A, Intervention model: Single Group Assignment, Intervention model description: 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, hypothermia will be administered for no longer than four hours., , Each patient will undergo maximum limb cooling. The initial device settings for the first cycle for each patient will be based on the optimal temperature determined to be safe and tolerable in previous studies. The temperature will be adjusted according to the patient's tolerance/intolerance feedback during each cycle of cooling and documented. , Masking: None (Open Label),


Chemotherapy-induced Peripheral Neuropathy

Other study ID numbers


Choose trial site (2)

Curie Oncology (Farrer)
3 Mount Elizabeth, #11-12 Medical Centre, Singapore 228510