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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03429972
• Other study ID #: 2015/3017
• Status: Recruiting
• Phase: Phase 2
• First received: November 9, 2017
• Last updated: March 13, 2018
• Start date: September 2016
• Est. completion date: June 2020

Study information

• Verified date: March 2018
• Source: National Cancer Centre, Singapore
• Contact: Dr Kiley Loh Wei-Jen, MD
• Phone: +65 6436 8000
• Email: kiley.loh.w.j[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 51
• Est. completion date: June 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Peripheral Nervous System Diseases

Intervention

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

Locations

Country	Name	City	State
Singapore	National Cancer Centre Singapore	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore	Duke-NUS Academic Medicine Research Institute, Singapore General Hospital, Terry Fox Foundation

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From commencement to completion of 12 paclitaxel infusions - estimated 3 months
Secondary	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
Secondary	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
Secondary	Incidence of adverse events, in cryotherapy arm versus controlled arm		From commencement to completion of 12 paclitaxel infusions - estimated 3 months
Secondary	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