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NCT Number: NCT05606068

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

Recruiting

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Key information

Conditions

Chemotherapy-induced Peripheral Neuropathy

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Curie Oncology, Mount Elizabeth Novena Specialist Centre, Singapore

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  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

    Time frame: 4 months

    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.

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

    Time frame: 16 months

    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.

Secondary outcomes

  1. PLCS usability questionnaire

    Time frame: 4 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aishwarya Bandla

CONTACT

[email protected]

Rachel Wong

CONTACT

[email protected]

6908 2222

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • Curie Oncology, Mount Elizabeth Novena Specialist Centre
  • National University of Singapore
  • Ng Teng Fong General Hospital
  • Paxman Coolers Ltd.

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2022
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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