Clinical trial NCT03429972: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Paclitaxel
Neuropathy
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: Terry Fox Foundation
name: Duke-NUS Academic Medicine Research Institute
name: Singapore General Hospital
First posted: 2018-02-12
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: From commencement to completion of 12 paclitaxel infusions - estimated 3 months
Secondary outcomes:
measure: 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
timeFrame: From commencement to completion of primary chemotherapy - estimated 15 months
measure: 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
timeFrame: From commencement to completion of primary chemotherapy - estimated 15 months
measure: Incidence of adverse events, in cryotherapy arm versus controlled arm
timeFrame: From commencement to completion of 12 paclitaxel infusions - estimated 3 months
measure: Proportion of patients reported intolerance and require cessation of therapies, in cryotherapy arm versus controlled arm
timeFrame: From commencement to completion of 12 paclitaxel infusions - estimated 3 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Dr Kiley Loh Wei-Jen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.