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

Phase 2

• Conditions: Breast Cancer
• Interventions: Device: Elasto-Gel™; Drug: Paclitaxel

• Registration Number: NCT03429972
• Lead Sponsor: National Cancer Centre, Singapore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-11-09
• Study First Submitted QC: 2018-02-05
• Study First Posted: 2018-02-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-13
• Last Update Posted: 2018-03-14
• Primary Completion: 2019-09
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 51

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel and Elasto-Gel™ Cryotherapy	Elasto-Gel™	Cryotherapy will be applied using Elasto-Gel™ hypothermia mitts and slippers for 15 minutes before, during and 15 minutes after each paclitaxel infusion.
Paclitaxel and Elasto-Gel™ Cryotherapy	Paclitaxel	Cryotherapy will be applied using Elasto-Gel™ hypothermia mitts and slippers for 15 minutes before, during and 15 minutes after each paclitaxel infusion.
Paclitaxel alone	Paclitaxel	Paclitaxel will be administered without cryotherapy.

Primary Outcome Measures

Name	Time	Method
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	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

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events, in cryotherapy arm versus controlled arm	From commencement to completion of 12 paclitaxel infusions - estimated 3 months
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	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	From commencement to completion of primary chemotherapy - estimated 15 months
Proportion of patients reported intolerance and require cessation of therapies, in cryotherapy arm versus controlled arm	From commencement to completion of 12 paclitaxel infusions - estimated 3 months

Trial Locations

Locations (1)

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore