PREventing CHemotherapy Induced Neuropathy (PreChIN)

Not Applicable

Completed

• Conditions: Chemotherapy-induced Peripheral Neuropathy (CIPN)
• Interventions: Device: Hypothermia; Device: Cryocompression

• Registration Number: NCT03299582
• Lead Sponsor: National University Hospital, Singapore

Brief 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.

Study Timeline

• Study Start: 2013-06-13
• Primary Completion: 2016-11-03
• Study Completion: 2017-02-15
• Status Verified: 2017-08
• Study First Submitted: 2017-09-11
• Study First Submitted QC: 2017-10-01
• Last Update Submitted: 2017-10-01
• Study First Posted: 2017-10-03
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Healthy subjects (Hypothermia)	Hypothermia	To investigate the safety and tolerability of limb hypothermia in subjects without cancer
Healthy subjects (Cryocompresion)	Cryocompression	To investigate the safety and tolerability of cryocompression in subjects without cancer
Cancer subjects (Hypothermia)	Hypothermia	To investigate the safety and tolerability of limb hypothermia in subjects with breast cancer being treated with paclitaxel chemotherapy.
Cancer subjects (Cryocompresion)	Cryocompression	To investigate the safety and tolerability of cryocompression in subjects with cancer being treated with taxane-based chemotherapy.

Primary Outcome Measures

Name	Time	Method
Number of healthy subjects with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression	From the start of assessment until study completion, an average of 3 years
Number of cancer patients with treatment-related intolerance as assessed by CTCAE v4.0 and tolerability scales undergoing limb hypothermia or cryocompression	From the start of assessment until study completion, an average of 3 years