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

NCT03429972 | Unknown Phase 2

• 1 other identifier: 2015/3017
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Paclitaxel; Neuropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Incidence of adverse events, in cryotherapy arm versus controlled arm

  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

  From commencement to completion of 12 paclitaxel infusions - estimated 3 months

Study Arms (2)

Paclitaxel and Elasto-Gel™ Cryotherapy

EXPERIMENTAL

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™; Drug: Paclitaxel

Paclitaxel alone

OTHER

Paclitaxel will be administered without cryotherapy.

Drug: Paclitaxel

Interventions

Elasto-Gel™ DEVICE

Elasto-Gel™ hypothermia mitts and slippers contain glycerine, which has thermal properties, allowing use for cold therapies.

Paclitaxel and Elasto-Gel™ Cryotherapy

Paclitaxel DRUG

80mg/m\^2 of Paclitaxel is administered by infusion for 60 mins once a week, for a total of 12 cycles

Paclitaxel alone; Paclitaxel and Elasto-Gel™ Cryotherapy

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Centre, Singapore: lead
• Terry Fox Foundation: collaborator
• Duke-NUS Academic Medicine Research Institute: collaborator
• Singapore General Hospital: collaborator

Study Sites (1)

National Cancer Centre Singapore

Singapore, 169610, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 33424755 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Dr Kiley Loh Wei-Jen, MD

  National Cancer Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Kiley Loh Wei-Jen, MD

CONTACT

+65 6436 8000; kiley.loh.w.j@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: February 12, 2018
• Study Start: September 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: June 1, 2020
• Last Updated: March 14, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)