NCT03299582

PREventing CHemotherapy Induced Neuropathy (PreChIN)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Chemotherapy-induced Peripheral Neuropathy (CIPN)

Interventions

Type	Name	Description
DEVICE	Hypothermia	Healthy subjects will undergo 3 hours of hypothermia at various temperature levels.Cancer subjects will undergo 4 hours of hypothermia during every cycle of chemotherapy.
DEVICE	Cryocompression	Healthy subjects will undergo 3 hours of cryocompression. Cancer subjects will undergo a minimum duration of 2 hours and a maximum duration of up to 4 hours of cryocompression during every cycle of chemotherapy.

Timeline

• Start date: 2013-06-13
• Primary completion: 2016-11-03
• Completion: 2017-02-15
• First posted: 2017-10-03
• Last updated: 2017-10-03