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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 21- 80 years. - Signed willing to sign a consent form from patient or legal representative - Scheduled to receive weekly paclitaxel chemotherapy - Patients may receive other chemotherapy drugs alongside taxane e.g. Platinum/Herceptin. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Treatments Being Tested

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.

Locations (2)

National University Hospital
Singapore, Singapore, Singapore
Curie Oncology, Mount Elizabeth Novena Specialist Centre
Singapore, Singapore, Singapore