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

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ClinicalTrials.gov Identifier: NCT05095051
Recruitment Status : Recruiting
First Posted : October 27, 2021
Last Update Posted : November 12, 2021
Sponsor:
Collaborators:
Paxman Coolers Ltd.
The N.1 Institute for Health, National University of Singapore
Information provided by (Responsible Party):
National University Hospital, Singapore

Brief Summary:
The study aims to investigate the safety and tolerability of limb cryocompression in preventing of Chemotherapy-induced Peripheral Neuropathy via a newly developed limb cryocompression device in healthy subjects and cancer patients. The limb cryocompression device will be tested for its safety in delivering limb cryocompression and efficacy in improving the preservation of peripheral nerves during chemotherapy.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Peripheral Neuropathy Device: Paxman Cryocompression System (PCCS) Not Applicable

Detailed Description:
The study consists of two parts. The first part of the study will consist of up to 18 healthy subjects to assess safety and tolerability of the new limb cryocompression device. The occurrence or lack of core hypothermia will be studied. The second part of the study will consist of 15 cancer patients recruited from the National University Hospital. Patients will undergo cryocompression over multiple cycles of chemotherapy to establish safety and tolerability 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Healthy subjects will undergo cryocompression of the various temperature and pressure levels in the cryocompression device. One temperature will be tested on 3 subjects for 3 hours. Tolerability of the temperature will be determined through a visual analogue pain scale (VAS). Should 1 out of 3 subjects display intolerance to the temperature level, 3 more healthy subjects will be tested to ensure consistency.

Cancer patient limb cryocompression sessions will comprise of a pre-cooling period, continued with paclitaxel infusion and a post-cooling period. 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 healthy subjects. Safety and tolerance of the concomitant cryocompression will be measured using VAS.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy
Actual Study Start Date : November 3, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Healthy subjects
To assess safety and tolerability of limb cryocompression, as well as to determine the optimal temperature and pressure to be used. The occurrence or lack of core hypothermia will be studied.
Device: Paxman Cryocompression System (PCCS)

Establishing optimal temperature and pressure for limb cryocompression therapy. Healthy subjects will undergo 3 hours of limb cryocompression.

The cryocompression device used in this study consists of a control unit, and limb wraps. The control unit contains the coolant reservoir and pump to circulate the coolant and air for compression. It is able to thermoregulate (control the temperature of the circulating coolant) and offer cyclic air pressure in the wraps. The wraps cover the limbs from the elbow/knee to the fingers/toes.


Experimental: Cancer patients
Once the optimal temperature and pressure of limb cryocompression is established in healthy subjects, a group of cancer patients will undergo limb cryocompression over multiple cycles of chemotherapy to establish safety and tolerability of repeated therapy.
Device: Paxman Cryocompression System (PCCS)

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

Paclitaxel will be administered as a one-hour infusion. Limb cryocompression sessions comprised of a pre-cooling period (up to one hour), continued with paclitaxel infusion and a post-cooling period (on average 30 minutes after the end of paclitaxel infusion). Overall, limb cryocompression will be administered for no longer than four hours.





Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events in healthy volunteers, over the duration of a limb cryocompression cycle, as assessed by Common Terminology Criteria for Adverse Events 5.0 [ Time Frame: During limb cryocompression procedure, 3 hours for healthy subject ]
    Defined as the number of subjects with treatment-related adverse events 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 tolerance scores in healthy volunteers, over the duration of a limb cryocompression cycle, as assessed by Visual Analogue Scale for pain [ Time Frame: During limb cryocompression procedure, 3 hours for healthy subject ]
    Defined as the number of subjects with treatment-related intolerance as assessed by tolerability scale, visual analog scale (VAS). On a scale of 0 to 10, a higher VAS score indicates higher intolerance. A score of 8 out of 10 will be considered dose-limiting intolerance.

  3. 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: During every cycle of paclitaxel chemotherapy (each cycle is 1 week) along with cryocompression which may last up to 4 hours, and for up to 12 cycles of weekly Paclitaxel treatment ]
    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.

  4. Difference in tolerance scores in cancer patients, over the duration of a limb cryocompression cycle, as assessed by Visual Analogue Scale for pain [ Time Frame: During every cycle of paclitaxel chemotherapy (each cycle is 1 week) along with cryocompression which may last up to 4 hours, and for up to 12 cycles of weekly Paclitaxel treatment ]
    Defined as the number of patients with treatment-related intolerance as assessed by tolerability scale, visual analog scale (VAS). On a scale of 0 to 10, a higher VAS score indicates higher intolerance. A score of 8 out of 10 will be considered dose-limiting intolerance.


Secondary Outcome Measures :
  1. Difference in tolerance scores between various temperature and pressure using Common Terminology Criteria for Adverse Events 4.0 and Visual Analogue Scale for pain [ Time Frame: During limb cryocompression procedure, 3 hours for healthy subject ]
    Difference in tolerance scores between various temperature and pressure as assessed by CTCAE v4.0 and tolerability scale, visual analog scale (VAS). On a scale of 0 to 10, a higher VAS score indicates higher intolerance. A score of 8 out of 10 will be considered dose-limiting intolerance.

  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: Before start of weekly paclitaxel chemotherapy, at the end of 12 cycles of weekly paclitaxel treatment, at 3-, 6-, and 12-months post-treatment ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. For healthy subjects:

    • Age 21-80 years
    • Signed informed consent from patient or legal representative
    • No history of neuropathy
    • ECOG 0
    • No history of hospitalization in the past 6 months
  2. For cancer patients:

    • 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:

  1. For healthy subjects:

    • Open skin wound or ulcers of the limbs
    • History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
    • Pregnant women
  2. For cancer patients:

    • Open skin wound or ulcers of the limbs
    • History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
    • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05095051


Contacts
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Contact: Raghav Sundar +65 6779 5555 raghav_sundar@nuhs.edu.sg
Contact: Aishwarya Bandla aishwarya.bandla@nus.edu.sg

Locations
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Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Raghav Sundar    +6567795555    raghav_sundar@nuhs.edu.sg   
Contact: Aishwarya Bandla       aishwarya.bandla@nus.edu.sg   
Principal Investigator: Raghav Sundar         
Sponsors and Collaborators
National University Hospital, Singapore
Paxman Coolers Ltd.
The N.1 Institute for Health, National University of Singapore
Investigators
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Principal Investigator: Raghav Sundar National University Hospital, Singapore
Publications:

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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT05095051    
Other Study ID Numbers: 2021/00288
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: November 12, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National University Hospital, Singapore:
Chemotherapy-induced Peripheral Neuropathy
Cryocompression
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases