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 limbs
History 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
Single group
Paxman Limb Cryocompression System (PLCS)
DeviceThe 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.
Incidence of Treatment-Emergent Adverse Events in cancer patients, over the duration of a limb cryocompression cycle, as assessed by Common Terminology Criteria for Adverse Events 5.0
Defined as the number of patients with treatment-related intolerance as assessed by CTCAE v5.0. Grade 1-5 refer to the severity of the adverse event with higher grade indicating greater severity. Grade 3 and above will be considered severe.
Difference in qualitative symptom scores using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale
Difference in qualitative symptom scores using the EORTC QLQ-CIPN-20 scale before, at the end of paclitaxel chemotherapy with limb cryocompression, and at 3,6 and 12 months post-treatment. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) has 20 questions/items. This scale has a minimum of 1 and maximum of 4 for each of the 20 questions, with higher scores indicating a worse outcome.
PLCS usability questionnaire
PLCS usability questionnaire will be given to patients after completing all 12 cycles of chemotherapy with cryocompression, to determine the tolerance level and user experience. The PLCS usability questionnaire has a total of 8 questions, some of which use a scale of 1 to 5, while other questions use a scale of 1 to 10. Some questions differ with regard to whether higher scores mean a better or worse outcome, but majority of the questions have higher scores indicating a better outcome.
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National University Hospital, Singapore
Lead sponsor
Paxman Coolers Ltd.
Collaborator
National University of Singapore
Collaborator
Curie Oncology, Mount Elizabeth Novena Specialist Centre
Collaborator
Ng Teng Fong General Hospital
Collaborator
