Chemotherapy-induced neuropathy.
Anthony J Windebank, Wolfgang Grisold
https://pubmed.ncbi.nlm.nih.gov/18346229Actively Recruiting
Phase Not Applicable
Age: 21Years - 80Years
All Genders
ID05606068
A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy - Expansion Study
Led by National University Hospital, Singapore · Updated on 2025-09-23
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
N
National University Hospital, Singapore
Lead Sponsor
P
Paxman Coolers Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new device called the Paxman Limb Cryocompression System (PLCS) to study its safety and effectiveness in preventing chemotherapy-induced peripheral neuropathy in cancer patients. This condition can cause nerve damage and discomfort during cancer treatment. The study will enroll 80 cancer patients receiving weekly paclitaxel chemotherapy, with some also receiving other chemotherapy drugs like Platinum or Herceptin. During the study, participants will undergo limb cryocompression using cooling wraps connected to the PLCS device. The cooling will be applied from the fingers or toes up to the elbow or knee during each chemotherapy cycle. Each cryocompression session will last up to four hours, including 30 minutes before and 30 minutes after chemotherapy infusion. Patients may continue treatment for up to 12 cycles or longer with their doctor's approval. Participants will be closely monitored for any treatment-related side effects using a standard scale over four months. Researchers will also assess symptom changes related to neuropathy over 16 months using a quality of life questionnaire. Patients will complete a usability survey about the PLCS device during the study. The total participation time varies with chemotherapy cycles, and safety will be carefully tracked throughout the study period.
CONDITIONS
Brief Title
A Novel Limb Cryocompression System for Prevention of Chemotherapy Induced Peripheral Neuropathy - Expansion Study
Who Can Participate
Age: 21Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 21 to 80 years
- Signed informed consent from patient or legal representative
- Scheduled to receive weekly paclitaxel chemotherapy
- Patients may receive other chemotherapy drugs alongside taxane, such as Platinum or Herceptin
You will not qualify if you...
- Open skin wounds or ulcers on the limbs
- History of Raynaud's phenomenon, peripheral vascular disease, or poorly controlled diabetes
- Pregnant women
- Total Neuropathy Score (TNS) greater than 5 at baseline for cancer patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 12 weeks or longer depending on chemotherapy cycles
Participants undergo limb cryocompression using a cooling device during each chemotherapy cycle to help prevent peripheral neuropathy.
Weekly visits during chemotherapy cycles with cryocompression applied for up to 4 hours per cycle
Trial Site Locations
Total: 2 locations
1
National University Hospital
Singapore, Singapore, Singapore, 119074
Actively Recruiting
2
Curie Oncology, Mount Elizabeth Novena Specialist Centre
Singapore, Singapore, Singapore, 329563
Not Yet Recruiting
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Research Team
S
Si Jing, Joline Lim
A
Aishwarya Bandla
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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Published Research Related To This Trial
Hypothermia for preventing chemotherapy-induced neuropathy - a pilot study on safety and tolerability in healthy controls.
Aishwarya Bandla, Raghav Sundar, Lun-De Liao...
https://pubmed.ncbi.nlm.nih.gov/26360921Limb Hypothermia for Preventing Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients: A Pilot Study.
Raghav Sundar, Aishwarya Bandla, Stacey Sze Hui Tan...
https://pubmed.ncbi.nlm.nih.gov/28119855Safety and tolerability of cryocompression as a method of enhanced limb hypothermia to reduce taxane-induced peripheral neuropathy.
Aishwarya Bandla, Stacey Tan, Nesaretnam Barr Kumarakulasinghe...
https://pubmed.ncbi.nlm.nih.gov/31811482Prevention and Management of Chemotherapy-Induced Peripheral Neuropathy in Survivors of Adult Cancers: ASCO Guideline Update.
Charles L Loprinzi, Christina Lacchetti, Jonathan Bleeker...
https://pubmed.ncbi.nlm.nih.gov/32663120Systemic anticancer therapy-induced peripheral and central neurotoxicity: ESMO-EONS-EANO Clinical Practice Guidelines for diagnosis, prevention, treatment and follow-up.
B Jordan, A Margulies, F Cardoso...
https://pubmed.ncbi.nlm.nih.gov/32739407NCCN task force report: management of neuropathy in cancer.
Michael D Stubblefield, Harold J Burstein, Allen W Burton...
https://pubmed.ncbi.nlm.nih.gov/19755042Minimal clinically important difference of the EORTC QLQ-CIPN20 for worsening peripheral neuropathy in patients receiving neurotoxic chemotherapy.
Fiona Yeo, Chiu Chin Ng, Kiley W J Loh...
https://pubmed.ncbi.nlm.nih.gov/30972646Are we mis-estimating chemotherapy-induced peripheral neuropathy? Analysis of assessment methodologies from a prospective, multinational, longitudinal cohort study of patients receiving neurotoxic chemotherapy.
Alex Molassiotis, Hui Lin Cheng, Violeta Lopez...
https://pubmed.ncbi.nlm.nih.gov/30736741Patient-reported (EORTC QLQ-CIPN20) versus physician-reported (CTCAE) quantification of oxaliplatin- and paclitaxel/carboplatin-induced peripheral neuropathy in NCCTG/Alliance clinical trials.
Jennifer Le-Rademacher, Rahul Kanwar, Drew Seisler...
https://pubmed.ncbi.nlm.nih.gov/28634656