PREventing CHemotherapy Induced Neuropathy (PreChIN)

October 1, 2017 updated by: National University Hospital, Singapore
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Amanda Chan, National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2013

Primary Completion (Actual)

November 3, 2016

Study Completion (Actual)

February 15, 2017

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

October 1, 2017

First Posted (Actual)

October 3, 2017

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

October 1, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/00343

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chemotherapy-induced Peripheral Neuropathy (CIPN)

Clinical Trials on Hypothermia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe