Concomitant Limb Cryocompression and Scalp Cooling to Reduce Paclitaxel-induced Neuropathy and Alopecia
Chemotherapy-induced Peripheral Neuropathy (CIPN)
About this trial
This is an interventional prevention trial for Chemotherapy-induced Peripheral Neuropathy (CIPN) focused on measuring paclitaxel, neuropathy, hypothermia, cryocompression, alopecia
Eligibility Criteria
The inclusion criterion for the healthy subjects:
- Age 21-80 years
- Signed informed consent from patient.
- No history of neuropathy
- ECOG 0
- No history of hospitalization in the past 6 months
The inclusion criteria for the cancer patients:
- Age 21- 80 years.
- Signed informed consent from patient
- Scheduled to receive weekly paclitaxel chemotherapy
For both healthy subjects and cancer patients:
- Open skin wound or ulcers of the limbs
- A score of more than 5 in the Total Neuropathy Score (TNS) at baseline (see outcome parameters) (Not applicable for healthy subjects)
- History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
Sites / Locations
- National University Hospital SingaporeRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Healthy subjects
Cancer subjects
To assess safety and tolerability of scalp and limb hypothermia, as well as to determine the optimal temperature and pressure to be used. Establishing the occurrence or lack of core hypothermia will be studied.
Once the optimal temperature and pressure of scalp and limb hypothermia is established in healthy patients, a group of cancer patients will undergo concomitant scalp and limb hypothermia over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy.