A randomized controlled study of cold therapy (cryotherapy) in the prevention of chemotherapy induced nerve damage in breast and gynaecological cancer patients.

The trial will enrol patients undergoing first line Taxane chemotherapy for treatment of breast or gynaecological cancer. Cryotherapy will be applied during Taxane chemotherapy via Medichill cool cubes, which are developed as an ice replacement pads (IRP)s. Cryotherapy will only be applied to patients randomized to the cryotherapy arm as per the randomization allocation; and will not be applied to patients randomized to the control arm. Patients will be required to have the IRP applied concurrently, starting 15 minutes prior to taxane infusion, during the duration of the taxane infusion, and until 15 minutes after the infusion finishes. Chemotherapy will be administered as per the standard protocol of the institution. IRP will be replaced at 30-minute intervals to ensure the cold temperature is maintained. Unless needing to be discontinued due to adverse event, patient request or investigator decision, cryotherapy will be continued until the final taxane administration of this planned treatment course. As per the product information, the Medichill® cool cubes require hydration first in water prior to freezing at -4°C for a minimum of 90 minutes.The IRP (ice replacement pads) will be prepared by soaking the product in a water unit until firm to touch (approximately 15 minutes) to rehydrate as per the product information, and then placed in a freezer at -4° C for a minimum of 90 mins. The freezer will be subjected to temperature monitoring as is routine by the hospital biomedical engineering department, and will be checked with themometers. The cool cubes will then be sized by the Associate Investigator (AI)/ Research Nurse (RN) as appropriate (the pallets of cubes can be cut with scissors to the appropriate size as per product information) and then covered with the Medichill® ice wrap cover.The PI, AI or RN will check to see that when the IRP is applied, the IRP covers the hands and feet to above the level of the wrist and ankle respectively, and the patient is not experiencing significant discomfort after the application. The IRP may need to be cut to size with scissors to allow appropriate coverage. Jewellery should be removed from the treatment areas if possible; if unable to be easily removed, rings or other jewellery should be taped with waterproof tape prior to application of the IRP. A bandage will be used to hold the IRP in place, and the bandage will be secured by water resistant tape. In patients randomised to cryotherapy, limb and digit neurovascular observations will be recorded every 30 minutes (at the same time as replacement with new IRP) by trial staff to monitor for patient tolerance and frostbite (ie direct application/ observation by study personnel). Regular changing of IRP is hypothesised to maintain skin temperatures similar to levels with scalp cryotherapy.