Breast CancerPhase 2NCT03429972
Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
A Phase 2 study testing Elasto-Gel™ and Paclitaxel in people with Breast Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Elasto-Gel™ and Paclitaxel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2016to Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 169610
Dr Kiley Loh Wei-Jen, MD, +65 6436 8000, kiley.loh.w.j@singhealth.com.sg
Dr Kiley Loh Wei-Jen, MD
About this study
Official title: Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Patients With Early and Locally Advanced Breast Cancer
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
- Being tested
- Elasto-Gel™, Paclitaxel
- Keywords
- Paclitaxel, Neuropathy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elasto-Gel™Device
Elasto-Gel™ hypothermia mitts and slippers contain glycerine, which has thermal properties, allowing use for cold therapies.
PaclitaxelDrug
80mg/m^2 of Paclitaxel is administered by infusion for 60 mins once a week, for a total of 12 cycles
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Elasto-Gel™; Drug: Paclitaxel |
| Paclitaxel alone | Other | Paclitaxel will be administered without cryotherapy. Receives: Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: From commencement to completion of primary chemotherapy - estimated 15 months
Incidence of adverse events, in cryotherapy arm versus controlled arm
Measured: 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
Measured: From commencement to completion of 12 paclitaxel infusions - estimated 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Terry Fox Foundation, Duke-NUS Academic Medicine Research Institute, Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Dr Kiley Loh Wei-Jen, MD, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429972
- Sponsor's protocol ID
- 2015/3017
- Status last verified
- Mar 2018
- First submitted
- 9 Nov 2017
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33424755
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Cryotherapy in Preventing Paclitaxel Induced Peripheral Neuropathy in Patients With Early and Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT03429972
- Acronym / sponsor ID
- 2015/3017
- Conditions
- Breast Cancer
- Keywords
- Paclitaxel, Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- Terry Fox Foundation, Duke-NUS Academic Medicine Research Institute, Singapore General Hospital
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel and Elasto-Gel™ Cryotherapy | Experimental | Device: Elasto-Gel™, Drug: PaclitaxelCryotherapy will be applied using Elasto-Gel™ hypothermia mitts and slippers for 15 minutes before, during and 15 minutes after each paclitaxel infusion. |
| Paclitaxel alone | Other | Drug: PaclitaxelPaclitaxel will be administered without cryotherapy. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elasto-Gel™Elasto-Gel™ hypothermia mitts and slippers contain glycerine, which has thermal properties, allowing use for cold therapies. | Device | Paclitaxel and Elasto-Gel™ Cryotherapy |
| Paclitaxel80mg/m^2 of Paclitaxel is administered by infusion for 60 mins once a week, for a total of 12 cycles | Drug | Paclitaxel alone, Paclitaxel and Elasto-Gel™ Cryotherapy |
Primary outcome
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
Time frame: 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
4 secondary outcomes
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
Time frame: 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
Time frame: From commencement to completion of primary chemotherapy - estimated 15 months
Incidence of adverse events, in cryotherapy arm versus controlled arm
Time frame: 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
Time frame: From commencement to completion of 12 paclitaxel infusions - estimated 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Derived from this study: PubMed 33424755Ng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Kiley Loh Wei-Jen, MD principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Elasto-Gel™ and Paclitaxel in people with Breast Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Kiley Loh Wei-Jen, MD (+65 6436 8000, kiley.loh.w.j@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From commencement to completion of 12 paclitaxel infusions - estimated 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2018.