A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy
NCT ID: NCT05095051
Last Updated: 2021-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
33 participants
INTERVENTIONAL
2021-11-03
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
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.
PREVENTION
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
80 Years
ALL
Yes
Sponsors
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Paxman Coolers Ltd.
UNKNOWN
The N.1 Institute for Health, National University of Singapore
UNKNOWN
National University Hospital, Singapore
OTHER
Responsible Party
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Principal Investigators
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Raghav Sundar
Role: PRINCIPAL_INVESTIGATOR
National University Hospital, Singapore
Locations
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National University Hospital
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Raghav Sundar
Role: primary
Aishwarya Bandla
Role: backup
References
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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.
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.
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.
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: [email protected]; EONS Education Working Group. Electronic address: [email protected]; EANO Guideline Committee. Electronic address: [email protected]. 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.
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.
Other Identifiers
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2021/00288
Identifier Type: -
Identifier Source: org_study_id