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Chemotherapy-induced Peripheral NeuropathyNCT05606068

A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy - Expansion Study

A study testing Paxman Limb Cryocompression System (PLCS) in people with Chemotherapy-induced Peripheral Neuropathy, run by National University Hospital, Singapore at 2 sites in Singapore.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The study conducted on cancer patients is designed to test safety and efficacy of limb hypothermia in cancer patients using the new Paxman Limb Cryocompression System (PLCS). Ultimately this will lead to the development of a therapy regime that will help to prevent chemotherapy-induced neuropathy in cancer patients. Read more about this study

Who is it for?
Ages 21 to 80 years
What is being tested?
Paxman Limb Cryocompression System (PLCS)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesSingapore
Study dates
11 Nov 2022to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 21- 80 years.
  • Signed informed consent from patient or legal representative
  • Scheduled to receive weekly paclitaxel chemotherapy
  • Patients may receive other chemotherapy drugs alongside taxane e.g. Platinum/Herceptin.

Who cannot join

  • Open skin wound or ulcers of the limbs
  • History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
  • Pregnant woman
  • A score of more than 5 in Total Neuropathy Score (TNS) at baseline for cancer patients

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rachel Wong contact

6908 2222

rachel_sj_wong@nuhs.edu.sg

Aishwarya Bandla contact

aishwarya.bandla@nus.edu.sg

Singapore2 sites, 2 recruiting

  • National University Hospital

    Singapore, 119074

    Rachel Wong, Medical Degree, 69082222, rachel_sj_wong@nuhs.edu.sg

    Aishwarya Bandla, aishwarya.bandla@nus.edu.sg

    Recruiting

  • Curie Oncology, Mount Elizabeth Novena Specialist Centre

    Singapore, 329563

    Lynette Ngo, 62595538

    Lynette Ngo

    Not yet recruiting

Other trials in Singapore

About this study

The study conducted on cancer patients is designed to test safety and efficacy of limb hypothermia in cancer patients using the new Paxman Limb Cryocompression System (PLCS). Ultimately this will lead to the development of a therapy regime that will help to prevent chemotherapy-induced neuropathy in cancer patients.

Read the detailed description

The study will consist of 200 cancer patients, recruited from the National University Hospital, Ng Teng Fong General Hospital and Curie Oncology. Based on an established optimal temperature and pressure of limb cryocompression, cancer patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and efficacy of repeated therapy. Cryocompression of the limbs will be administered using cooling wraps attached to a cooling device. The limbs will be cooled from the digits to the elbow/knee.

Being tested
Paxman Limb Cryocompression System (PLCS)
Keywords
Chemotherapy-induced Peripheral Neuropathy, Cryocompression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paxman Limb Cryocompression System (PLCS)Device

    The study population will comprise of cancer patients scheduled to receive weekly paclitaxel chemotherapy for a maximum of 12 cycles.

    Cryocompression will be applied during every cycle of chemotherapy for a duration of up to 4 hours. All chemotherapy patients will receive 30 minutes pre-infusion cooling and 30 minutes post-infusion cooling. Cryocompression for each cycle will not exceed 4 hours. Chemotherapy and concomitant limb cryocompression are performed for 12 cycles and may be continued further in consultation with the PI. Overall, limb cryocompression will be administered for no longer than four hours.

Study groups in NCT05606068
Study groupRoleWhat they receive
Cancer patientsExperimentalCancer patients will undergo limb cryocompression based on the established optimal temperature and pressure from previous studies over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy.
Receives: Device: Paxman Limb Cryocompression System (PLCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events in cancer patients, over the duration of a limb cryocompression cycle, as assessed by Common Terminology Criteria for Adverse Events 5.0

    Defined as the number of patients with treatment-related intolerance as assessed by CTCAE v5.0. Grade 1-5 refer to the severity of the adverse event with higher grade indicating greater severity. Grade 3 and above will be considered severe.

    Measured: 4 months

  2. Difference in qualitative symptom scores using the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale

    Difference in qualitative symptom scores using the EORTC QLQ-CIPN-20 scale before, at the end of paclitaxel chemotherapy with limb cryocompression, and at 3,6 and 12 months post-treatment.

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy-Induced Peripheral Neuropathy Module (EORTC QLQ-CIPN20) has 20 questions/items. This scale has a minimum of 1 and maximum of 4 for each of the 20 questions, with higher scores indicating a worse outcome.

    Measured: 16 months

Secondary outcomes (1)

  1. PLCS usability questionnaire

    PLCS usability questionnaire will be given to patients after completing all 12 cycles of chemotherapy with cryocompression, to determine the tolerance level and user experience. The PLCS usability questionnaire has a total of 8 questions, some of which use a scale of 1 to 5, while other questions use a scale of 1 to 10. Some questions differ with regard to whether higher scores mean a better or worse outcome, but majority of the questions have higher scores indicating a better outcome.

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study start11 Nov 2022
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

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 N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
Cryocompression will be applied during every cycle of chemotherapy for a duration of up to 4 hours. All chemotherapy patients will receive 30 minutes pre-infusion cooling and 30 minutes post-infusion cooling. Cryocompression for each cycle will not exceed 4 hours. Chemotherapy and concomitant limb cryocompression are performed for 12 cycles and may be continued further in consultation with the PI. Overall, hypothermia will be administered for no longer than four hours. Each patient will undergo maximum limb cooling. The initial device settings for the first cycle for each patient will be based on the optimal temperature determined to be safe and tolerable in previous studies. The temperature will be adjusted according to the patient's tolerance/intolerance feedback during each cycle of cooling and documented.
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05606068
Sponsor's protocol ID
2022/00486
Status last verified
Sep 2025
First submitted
25 Oct 2022
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Windebank AJ, Grisold W. Chemotherapy-induced neuropathy. J Peripher Nerv Syst. 2008 Mar;13(1):27-46. doi: 10.1111/j.1529-8027.2008.00156.x.

    PubMed 18346229

  • Bandla A, Sundar R, Liao LD, Sze Hui Tan S, Lee SC, Thakor NV, Wilder-Smith EP. Hypothermia for preventing chemotherapy-induced neuropathy - a pilot study on safety and tolerability in healthy controls. Acta Oncol. 2016;55(4):430-6. doi: 10.3109/0284186X.2015.1075664. Epub 2015 Sep 11.

    PubMed 26360921

  • Sundar R, Bandla A, Tan SS, Liao LD, Kumarakulasinghe NB, Jeyasekharan AD, Ow SG, Ho J, Tan DS, Lim JS, Vijayan J, Therimadasamy AK, Hairom Z, Ang E, Ang S, Thakor NV, Lee SC, Wilder-Smith EP. Limb Hypothermia for Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Study. Front Oncol. 2017 Jan 10;6:274. doi: 10.3389/fonc.2016.00274. eCollection 2016.

    PubMed 28119855

  • Bandla A, Tan S, Kumarakulasinghe NB, Huang Y, Ang S, Magarajah G, Hairom Z, Lim JSJ, Wong A, Chan G, Ngoi N, Ang E, Lee YM, Chan A, Lee SC, Thakor N, Wilder-Smith E, Sundar R. Safety and tolerability of cryocompression as a method of enhanced limb hypothermia to reduce taxane-induced peripheral neuropathy. Support Care Cancer. 2020 Aug;28(8):3691-3699. doi: 10.1007/s00520-019-05177-2. Epub 2019 Dec 6.

    PubMed 31811482

  • Loprinzi CL, Lacchetti C, Bleeker J, Cavaletti G, Chauhan C, Hertz DL, Kelley MR, Lavino A, Lustberg MB, Paice JA, Schneider BP, Lavoie Smith EM, Smith ML, Smith TJ, Wagner-Johnston N, Hershman DL. Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: ASCO Guideline Update. J Clin Oncol. 2020 Oct 1;38(28):3325-3348. doi: 10.1200/JCO.20.01399. Epub 2020 Jul 14.

    PubMed 32663120

  • Jordan B, Margulies A, Cardoso F, Cavaletti G, Haugnes HS, Jahn P, Le Rhun E, Preusser M, Scotte F, Taphoorn MJB, Jordan K; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org; EONS Education Working Group. Electronic address: eons.secretariat@cancernurse.eu; EANO Guideline Committee. Electronic address: office@eano.eu. Systemic anticancer therapy-induced peripheral and central neurotoxicity: ESMO-EONS-EANO Clinical Practice Guidelines for diagnosis, prevention, treatment and follow-up. Ann Oncol. 2020 Oct;31(10):1306-1319. doi: 10.1016/j.annonc.2020.07.003. Epub 2020 Jul 30. No abstract available.

    PubMed 32739407

  • Stubblefield MD, Burstein HJ, Burton AW, Custodio CM, Deng GE, Ho M, Junck L, Morris GS, Paice JA, Tummala S, Von Roenn JH. NCCN task force report: management of neuropathy in cancer. J Natl Compr Canc Netw. 2009 Sep;7 Suppl 5:S1-S26; quiz S27-8. doi: 10.6004/jnccn.2009.0078.

    PubMed 19755042

  • Yeo F, Ng CC, Loh KWJ, Molassiotis A, Cheng HL, Au JSK, Leung KT, Li YC, Wong KH, Suen L, Chan CW, Yorke J, Farrell C, Bandla A, Ang E, Lopez V, Sundar R, Chan A. Minimal clinically important difference of the EORTC QLQ-CIPN20 for worsening peripheral neuropathy in patients receiving neurotoxic chemotherapy. Support Care Cancer. 2019 Dec;27(12):4753-4762. doi: 10.1007/s00520-019-04771-8. Epub 2019 Apr 10.

    PubMed 30972646

  • Molassiotis A, Cheng HL, Lopez V, Au JSK, Chan A, Bandla A, Leung KT, Li YC, Wong KH, Suen LKP, Chan CW, Yorke J, Farrell C, Sundar R. Are we mis-estimating chemotherapy-induced peripheral neuropathy? Analysis of assessment methodologies from a prospective, multinational, longitudinal cohort study of patients receiving neurotoxic chemotherapy. BMC Cancer. 2019 Feb 8;19(1):132. doi: 10.1186/s12885-019-5302-4.

    PubMed 30736741

  • Le-Rademacher J, Kanwar R, Seisler D, Pachman DR, Qin R, Abyzov A, Ruddy KJ, Banck MS, Lavoie Smith EM, Dorsey SG, Aaronson NK, Sloan J, Loprinzi CL, Beutler AS. Patient-reported (EORTC QLQ-CIPN20) versus physician-reported (CTCAE) quantification of oxaliplatin- and paclitaxel/carboplatin-induced peripheral neuropathy in NCCTG/Alliance clinical trials. Support Care Cancer. 2017 Nov;25(11):3537-3544. doi: 10.1007/s00520-017-3780-y. Epub 2017 Jun 20.

    PubMed 28634656

Questions about this trial

What is this clinical trial studying?

A study testing Paxman Limb Cryocompression System (PLCS) in people with Chemotherapy-induced Peripheral Neuropathy, run by National University Hospital, Singapore at 2 sites 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rachel Wong (6908 2222, rachel_sj_wong@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events in cancer patients, over the duration of a limb cryocompression cycle, as assessed by Common Terminology Criteria for Adverse Events 5.0 (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT05606068, which also lists 10 linked publications.

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 22 Jun 2026.

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