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

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

The study aims to investigate the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy via a newly developed limb cryocompression device in healthy subjects and cancer patients. The limb cryocompression device will be tested for its safety in delivering limb cryocompression and efficacy in improving the preservation of peripheral nerves during chemotherapy.

The study consists of two parts. The first part of the study will consist of up to 18 healthy subjects to assess safety and tolerability of the new limb cryocompression device. The occurrence or lack of core hypothermia will be studied. The second part of the study will consist of 15 cancer patients recruited from the National University Hospital. Patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy. Cryocompression of the limbs will be administered using cooling wraps attached to a cooling device. The limbs will be cooled from the digits to the elbow/knee.

Inclusion Criteria:

1. For healthy subjects:

   • Age 21-80 years
   • Signed informed consent from patient or legal representative
   • No history of neuropathy
   • ECOG 0
   • No history of hospitalization in the past 6 months

2. For 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.

Exclusion Criteria:

1. For healthy subjects:

   • Open skin wound or ulcers of the limbs
   • History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
   • Pregnant women

2. For cancer patients:

   • Open skin wound or ulcers of the limbs
   • History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
   • Pregnant women