Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients

March 13, 2018 updated by: National Cancer Centre, Singapore

Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Patients With Early and Locally Advanced Breast Cancer

The trial will be preceded by a pilot phase study in 5 patients.

This will then be followed by the randomized 1:1 phase II trial testing the utility of regional cryotherapy in preventing or reducing paclitaxel-induced peripheral neuropathy compared to no treatment.

It is hypothesized that cryotherapy causes regional blood vessel constriction and decreases the paclitaxel exposure to the distal epithelial nerve fibres, thus resulting in decreased nerve damage.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
51

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Singapore
      • Singapore, Singapore, 169610
        • Recruiting
        • National Cancer Centre Singapore
        • Contact:
        • Principal Investigator:
          • Dr Kiley Loh Wei-Jen, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Provision of written informed consent prior to any study specific procedures.
  2. Age ≥ 21 years old
  3. Patients with histologically confirmed early or locally advanced breast cancer
  4. Must be receiving 12x weekly sessions of paclitaxel as part of their adjuvant or neo-adjuvant chemotherapy
  5. Must have routine chemotherapy lab investigations as per institutional practice
  6. Concurrent use of Trastuzumab and/or Pertuzumab for cerbB-2 positive patients as per institutional practice is allowed
  7. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations.

Exclusion Criteria:

  1. Patients diagnosed with pre-existing or history of peripheral neuropathy (regardless of cause)
  2. Patients with history of Raynaud's disease
  3. Prior use of taxane-based chemotherapy
  4. Concurrent use of other neuro-toxic chemotherapy with paclitaxel
  5. Patients who have had any axillary clearance surgery and without a central venous access device for chemotherapy administration
  6. Patients with any severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation in the clinical study.

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Paclitaxel and Elasto-Gel™ Cryotherapy
Cryotherapy will be applied using Elasto-Gel™ hypothermia mitts and slippers for 15 minutes before, during and 15 minutes after each paclitaxel infusion.
Device: Elasto-Gel™
Elasto-Gel™ hypothermia mitts and slippers contain glycerine, which has thermal properties, allowing use for cold therapies.
Drug: Paclitaxel
80mg/m^2 of Paclitaxel is administered by infusion for 60 mins once a week, for a total of 12 cycles
OTHER: Paclitaxel alone
Paclitaxel will be administered without cryotherapy.
Drug: Paclitaxel
80mg/m^2 of Paclitaxel is administered by infusion for 60 mins once a week, for a total of 12 cycles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients reporting level C and above subjective symptoms, in cryotherapy arm versus controlled arm, based on the Patient Neurotoxicity Questionnaire (PNQ) at 3 months after baseline
Time Frame: From commencement to completion of 12 paclitaxel infusions - estimated 3 months
PNQ scale ranges from scores A to E; with scoring of A being not affected neuropathy, and E with the worst neuropathy
From commencement to completion of 12 paclitaxel infusions - estimated 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of patients reporting level C and above subjective symptoms, in cryotherapy arm versus controlled arm, based on the Patient Neurotoxicity Questionnaire (PNQ) at 15 months after baseline
Time Frame: From commencement to completion of primary chemotherapy - estimated 15 months
From commencement to completion of primary chemotherapy - estimated 15 months
Proportion of patients with lower sensory velocity and amplitudes (based on nerve conduction tests), in cryotherapy arm versus controlled arm, at 15 months after baseline
Time Frame: From commencement to completion of primary chemotherapy - estimated 15 months
From commencement to completion of primary chemotherapy - estimated 15 months
Incidence of adverse events, in cryotherapy arm versus controlled arm
Time Frame: From commencement to completion of 12 paclitaxel infusions - estimated 3 months
From commencement to completion of 12 paclitaxel infusions - estimated 3 months
Proportion of patients reported intolerance and require cessation of therapies, in cryotherapy arm versus controlled arm
Time Frame: From commencement to completion of 12 paclitaxel infusions - estimated 3 months
From commencement to completion of 12 paclitaxel infusions - estimated 3 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Cancer Centre, Singapore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Singapore General Hospital
Terry Fox Foundation
Duke-NUS Academic Medicine Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr Kiley Loh Wei-Jen, MD, National Cancer Centre, 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015/3017

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.

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