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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Elasto-Gel™
Paclitaxel
Sponsored by
National Cancer Centre, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Paclitaxel, Neuropathy

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Centre SingaporeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Paclitaxel and Elasto-Gel™ Cryotherapy

Paclitaxel alone

Arm Description

Cryotherapy will be applied using Elasto-Gel™ hypothermia mitts and slippers for 15 minutes before, during and 15 minutes after each paclitaxel infusion.

Paclitaxel will be administered without cryotherapy.

Outcomes

Primary Outcome Measures

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
PNQ scale ranges from scores A to E; with scoring of A being not affected neuropathy, and E with the worst neuropathy

Secondary Outcome Measures

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
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
Incidence of adverse events, in cryotherapy arm versus controlled arm
Proportion of patients reported intolerance and require cessation of therapies, in cryotherapy arm versus controlled arm

Full Information

First Posted
November 9, 2017
Last Updated
March 13, 2018
Sponsor
National Cancer Centre, Singapore
Collaborators
Terry Fox Foundation, Duke-NUS Academic Medicine Research Institute, Singapore General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03429972
Brief Title
Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Official Title
Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Patients With Early and Locally Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Centre, Singapore
Collaborators
Terry Fox Foundation, Duke-NUS Academic Medicine Research Institute, Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Paclitaxel, Neuropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paclitaxel and Elasto-Gel™ Cryotherapy
Arm Type
Experimental
Arm Description
Cryotherapy will be applied using Elasto-Gel™ hypothermia mitts and slippers for 15 minutes before, during and 15 minutes after each paclitaxel infusion.
Arm Title
Paclitaxel alone
Arm Type
Other
Arm Description
Paclitaxel will be administered without cryotherapy.
Intervention Type
Device
Intervention Name(s)
Elasto-Gel™
Intervention Description
Elasto-Gel™ hypothermia mitts and slippers contain glycerine, which has thermal properties, allowing use for cold therapies.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
80mg/m^2 of Paclitaxel is administered by infusion for 60 mins once a week, for a total of 12 cycles
Primary Outcome Measure Information:
Title
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
Description
PNQ scale ranges from scores A to E; with scoring of A being not affected neuropathy, and E with the worst neuropathy
Time Frame
From commencement to completion of 12 paclitaxel infusions - estimated 3 months
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Incidence of adverse events, in cryotherapy arm versus controlled arm
Time Frame
From commencement to completion of 12 paclitaxel infusions - estimated 3 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of written informed consent prior to any study specific procedures. Age ≥ 21 years old Patients with histologically confirmed early or locally advanced breast cancer Must be receiving 12x weekly sessions of paclitaxel as part of their adjuvant or neo-adjuvant chemotherapy Must have routine chemotherapy lab investigations as per institutional practice Concurrent use of Trastuzumab and/or Pertuzumab for cerbB-2 positive patients as per institutional practice is allowed 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: Patients diagnosed with pre-existing or history of peripheral neuropathy (regardless of cause) Patients with history of Raynaud's disease Prior use of taxane-based chemotherapy Concurrent use of other neuro-toxic chemotherapy with paclitaxel Patients who have had any axillary clearance surgery and without a central venous access device for chemotherapy administration Patients with any severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation in the clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Kiley Loh Wei-Jen, MD
Phone
+65 6436 8000
Email
kiley.loh.w.j@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Kiley Loh Wei-Jen, MD
Organizational Affiliation
National Cancer Centre, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Centre Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Kiley Loh Wei-Jen, MD
Phone
+65 6436 8000
Email
kiley.loh.w.j@singhealth.com.sg
First Name & Middle Initial & Last Name & Degree
Dr Kiley Loh Wei-Jen, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33424755
Citation
Ng DQ, Tan CJ, Soh BC, Tan MML, Loh SY, Tan YE, Ong HH, Teng PPC, Chan JJ, Chay WY, Lee J, Lai G, Beh SY, Tan TJY, Yap YS, Lee GE, Wong M, Dent R, Lo YL, Chan A, Loh KW. Impact of Cryotherapy on Sensory, Motor, and Autonomic Neuropathy in Breast Cancer Patients Receiving Paclitaxel: A Randomized, Controlled Trial. Front Neurol. 2020 Dec 18;11:604688. doi: 10.3389/fneur.2020.604688. eCollection 2020.
Results Reference
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Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients

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