| Registry | NCT03299582 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; non randomized, sequential, masking: none, prevention |
| Enrollment | 89 (Actual) |
| Sponsor | National University Hospital, Singapore (Other) |
| Conditions | Chemotherapy-induced Peripheral Neuropathy (CIPN) |
| Interventions | Hypothermia, Cryocompression (Device) |
| Dates | start 2013-06-13, primary completion 2016-11-03, completion 2017-02-15, first posted 2017-10-03, last updated 2017-10-03 |
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All trials for Chemotherapy-induced Peripheral Neuropathy (CIPN) All trials of Hypothermia All trials of Cryocompression
The project is designed to study the use of localized hypothermia alone, or with compression to the limbs during chemotherapy infusion for the prevention of chemotherapy induced peripheral neuropathy (CIPN). As a pilot study, safety, tolerability and early clinical activity will be studied. The study will be conducted on healthy volunteers and cancer patients receiving taxane chemotherapy.
Localized limb hypothermia during chemotherapeutic infusion may prevent a common side effect of chemotherapy: chemotherapy-induced peripheral neuropathy (CIPN). There are no reliable methods for the prevention or the treatment of CIPN. On the basis of the dose-related pathophysiology of CIPN, the investigators hypothesize that reducing the delivery of the toxic chemotherapeutic agents to the peripheral nerves by reducing blood flow through hypothermia may reduce the occurrence of CIPN. The proposed potential treatment method would aim to reduce the development of CIPN. This project comprises of a healthy subject trial to investigate the best tolerated temperature which will be used in cancer subject trial to investigate the safety and tolerability of hypothermia or cryocompression (hypothermia with pressure) in the prevention of CIPN in cancer subjects undergoing taxane-based chemotherapy.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Healthy subjects (Hypothermia) | Experimental | Device: Hypothermia | To investigate the safety and tolerability of limb hypothermia in subjects without cancer |
| Healthy subjects (Cryocompresion) | Experimental | Device: Cryocompression | To investigate the safety and tolerability of cryocompression in subjects without cancer |
| Cancer subjects (Hypothermia) | Experimental | Device: Hypothermia | To investigate the safety and tolerability of limb hypothermia in subjects with breast cancer being treated with paclitaxel chemotherapy. |
| Cancer subjects (Cryocompresion) | Experimental | Device: Cryocompression | To investigate the safety and tolerability of cryocompression in subjects with cancer being treated with taxane-based chemotherapy. |
Sex: All, ages: 21 Years to 80 Years, accepts healthy volunteers
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 undergoing taxane-based chemotherapy * Age 21- 80 years. * Signed informed consent from patient or legal representative. * Scheduled to receive taxane-based chemotherapy The exclusion criteria 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 (Not applicable for healthy subjects) * History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes