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

National Cancer Centre, Singapore

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Device: Elasto-Gel™; Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT03429972

2015/3017

Details and patient eligibility

About

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.

Enrollment: 51 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Paclitaxel and Elasto-Gel™ Cryotherapy

Experimental group

Description:

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

Treatment:

Drug: Paclitaxel

Device: Elasto-Gel™

Paclitaxel alone

Other group

Description:

Paclitaxel will be administered without cryotherapy.

Treatment:

Drug: Paclitaxel